## Protocol Section
### Identification Module
**NCT ID:** NCT04677179

**Acronym:** INSTRUCT-UC

**Brief Title:** A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

**Official Title:** An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis

#### Organization Study ID Info
**ID:** 17287
#### Organization
**Class:** INDUSTRY
**Full Name:** Nektar Therapeutics
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** J1P-MC-KFAH
**Type:** OTHER
**ID:** 2020-003017-35
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2022-08-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-08

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2022-08-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-09-05

**Type:** ACTUAL

**Results First Submit Date:** 2023-08-08

**Results First Submit QC Date:** 2023-08-08

#### Start Date
**Date:** 2021-03-22

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2020-12-21
**Type:** ACTUAL
**Study First Submit Date:** 2020-12-08
**Study First Submit QC Date:** 2020-12-17
**Why Stopped:** Study terminated due to enrollment futility.
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Nektar Therapeutics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

**Detailed Description:** In stage 1, two doses (high and low) of LY3471851 will be compared to placebo. In stage 2, up to two additional doses (to be confirmed) of LY3471851 will be compared to placebo.

LY3471851 (NKTR-358) is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

### Conditions Module

**Conditions:**

- Colitis, Ulcerative

**Keywords:**

- T regulatory cells (Tregs)

- Interleukin 2

- Interleukin-2

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 81

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.

**Intervention Names:**

- Drug: LY3471851

**Label:** High dose LY3471851

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.

**Intervention Names:**

- Drug: LY3471851

**Label:** Low dose LY3471851

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.

**Intervention Names:**

- Drug: LY3471851

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High dose LY3471851

- Low dose LY3471851

- Placebo

**Description:** administered SC

**Name:** LY3471851

**Other Names:**

- NKTR-358

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** administered SC

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

**Measure:** Percentage of Participants Who Achieved Clinical Remission at Week 12

**Time Frame:** Week 12

#### Secondary Outcomes

**Description:** Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

**Measure:** Percentage of Participants Who Achieved Clinical Response at Week 12

**Time Frame:** Week 12

**Description:** Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

**Measure:** Percentage of Participants Who Achieved Endoscopic Remission at Week 12

**Time Frame:** Week 12

**Description:** Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

**Measure:** Percentage of Participants Who Achieved Endoscopic Response at Week 12

**Time Frame:** Week 12

**Description:** Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

**Measure:** Percentage of Participants Who Achieved Symptomatic Remission at Week 12

**Time Frame:** Week 12

**Description:** Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

**Measure:** Percentage of Participants Who Achieved Symptomatic Response at Week 12

**Time Frame:** Week 12

**Description:** Histologic Remission is defined as Geboes score \<2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=\>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.

**Measure:** Percentage of Participants Who Achieved Histologic Remission at Week 12

**Time Frame:** Week 12

**Description:** HEMH is defined as Geboes score \<2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=\>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).

**Measure:** Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)

**Time Frame:** Week 12

**Description:** IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: \[4 to 6\] or \[7 to 9\]) and region (North America/Europe/Other) as fixed factors.

**Measure:** Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score

**Time Frame:** Baseline, Week 12

**Description:** C-trough is the concentration of drug in the blood immediately before the next dose was administered.

**Measure:** Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12

**Time Frame:** Predose at week 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) ≥2, with endoscopy performed within 14 days before baseline.
* Have evidence of UC extending proximal to the rectum (with ≥15 centimeters (cm) of involved colon).
* Have up-to-date colorectal cancer surveillance performed according to local standard.
* Participants are either one of the following:
* Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
* Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor \[TNF\] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase \[JAK\] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment.
* Have had an established diagnosis of UC of ≥3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents.
* Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug.

Exclusion Criteria:

* Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.
* Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of screening.
* Have had or will need abdominal surgery for UC (for example, subtotal colectomy).
* Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor \[TNF\] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase \[JAK\] inhibitor).
* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
* Have any history or evidence of cancer of the gastrointestinal tract
* Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Litchfield Park

**Country:** United States

**Facility:** Dedicated Clinical Research

**State:** Arizona

**Zip:** 85340

**Location 2:**

**City:** Kissimmee

**Country:** United States

**Facility:** I.H.S. Health, LLC

**State:** Florida

**Zip:** 34741

**Location 3:**

**City:** Pensacola

**Country:** United States

**Facility:** Gastroenterology Associates of Pensacola, PA

**State:** Florida

**Zip:** 32503

**Location 4:**

**City:** Morristown

**Country:** United States

**Facility:** Atlantic Digestive Health Institute

**State:** New Jersey

**Zip:** 07960

**Location 5:**

**City:** Houston

**Country:** United States

**Facility:** Biopharma Informatic, LLC

**State:** Texas

**Zip:** 77084

**Location 6:**

**City:** San Antonio

**Country:** United States

**Facility:** Southern Star Research Institute, LLC

**State:** Texas

**Zip:** 78229

**Location 7:**

**City:** Ogden

**Country:** United States

**Facility:** Care Access Research - Ogden

**State:** Utah

**Zip:** 84403

**Location 8:**

**City:** Caba

**Country:** Argentina

**Facility:** DOM- Centro de Reumatologia

**State:** Buenos Aires

**Zip:** 1111

**Location 9:**

**City:** Caba

**Country:** Argentina

**Facility:** Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC

**State:** Buenos Aires

**Zip:** C1431FWO

**Location 10:**

**City:** Ciudad Autonoma De Buenos Air

**Country:** Argentina

**Facility:** Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

**State:** Buenos Aires

**Zip:** C1128AAF

**Location 11:**

**City:** Tucumán

**Country:** Argentina

**Facility:** Centro Médico Privado de Reumatología

**Zip:** T4000AXL

**Location 12:**

**City:** Concord

**Country:** Australia

**Facility:** Concord Repatriation General Hospital

**State:** New South Wales

**Zip:** 2139

**Location 13:**

**City:** Albion

**Country:** Australia

**Facility:** Paratus Clinical Research Brisbane

**State:** Queensland

**Zip:** 4010

**Location 14:**

**City:** South Brisbane

**Country:** Australia

**Facility:** Mater Adult Hospital Brisbane

**State:** Queensland

**Zip:** 4700

**Location 15:**

**City:** Fitzroy

**Country:** Australia

**Facility:** St. Vincent's Hospital

**State:** Victoria

**Zip:** 3065

**Location 16:**

**City:** Brussels

**Country:** Belgium

**Facility:** Université Libre de Bruxelles - Hôpital Erasme

**State:** Bruxelles-Capitale, Région De

**Zip:** 1070

**Location 17:**

**City:** Tournai

**Country:** Belgium

**Facility:** Centre Hospitalier de Wallonie Picarde - Site Notre Dame

**State:** Wallonne, Région

**Zip:** 7500

**Location 18:**

**City:** Gent

**Country:** Belgium

**Facility:** AZ Maria Middelares

**Zip:** 9100

**Location 19:**

**City:** Brasília

**Country:** Brazil

**Facility:** Chronos Pesquisa Clínica

**State:** Distrito Federal

**Zip:** 72145-450

**Location 20:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

**State:** Rio Grande Do Sul

**Zip:** 90430-001

**Location 21:**

**City:** Campinas

**Country:** Brazil

**Facility:** HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

**State:** Sao Paulo

**Zip:** 13060-904

**Location 22:**

**City:** Santo Andre

**Country:** Brazil

**Facility:** Pesquisare

**State:** Sao Paulo

**Zip:** 09080-110

**Location 23:**

**City:** Sao Paulo

**Country:** Brazil

**Facility:** Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

**State:** SP

**Zip:** 04039-004

**Location 24:**

**City:** Botucatu

**Country:** Brazil

**Facility:** Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

**State:** São Paulo

**Zip:** 18618-687

**Location 25:**

**City:** São Bernardo do Campo

**Country:** Brazil

**Facility:** CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

**State:** São Paulo

**Zip:** 09715-090

**Location 26:**

**City:** Sao Paulo

**Country:** Brazil

**Facility:** Hepatogastro

**Zip:** 04543-001

**Location 27:**

**City:** Edmonton

**Country:** Canada

**Facility:** Gastroenterology and internal medicine research institute

**State:** Alberta

**Zip:** T5R 1W2

**Location 28:**

**City:** Halifax

**Country:** Canada

**Facility:** Gastroenterology Research, Nova Scotia Health Authority

**State:** Nova Scotia

**Zip:** B3H2Y9

**Location 29:**

**City:** Greenfield Park

**Country:** Canada

**Facility:** CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne

**State:** Quebec

**Zip:** J4V2H1

**Location 30:**

**City:** Montreal

**Country:** Canada

**Facility:** McGill University

**State:** Quebec

**Zip:** H3G 1A4

**Location 31:**

**City:** HefeiCity

**Country:** China

**Facility:** The First Affiliated Hospital of Anhui Medical University

**State:** Anhui

**Zip:** 230022

**Location 32:**

**City:** Guangzhou

**Country:** China

**Facility:** First affiliated Hospital of Sun Yat-Sen University

**State:** Guangdong

**Zip:** 510080

**Location 33:**

**City:** Guangzhou

**Country:** China

**Facility:** The Sixth Affiliated Hospital, Sun Yat-Sen University

**State:** Guangdong

**Zip:** 510655

**Location 34:**

**City:** Wu Han

**Country:** China

**Facility:** Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

**State:** Hubei

**Zip:** 430030

**Location 35:**

**City:** Wuhan

**Country:** China

**Facility:** Union Hospital Tongji Medical College Huazhong University of Science and Technology

**State:** Hubei

**Zip:** 430022

**Location 36:**

**City:** Nanchang

**Country:** China

**Facility:** The First Affiliated Hospital of Nanchang University

**State:** Jiangxi

**Zip:** 330006

**Location 37:**

**City:** Taian

**Country:** China

**Facility:** Taian City Central Hospital

**State:** Shandong

**Zip:** 271000

**Location 38:**

**City:** Shanghai

**Country:** China

**Facility:** Shanghai Jiaotong University School of Medicine Ruijin Hospital

**State:** Shanghai

**Zip:** 200025

**Location 39:**

**City:** Hangzhou

**Country:** China

**Facility:** Sir Run Run Shaw Hospital

**State:** Zhejiang

**Zip:** 310018

**Location 40:**

**City:** Pilsen

**Country:** Czechia

**Facility:** A-Shine

**State:** Plzeň-město

**Zip:** 312 00

**Location 41:**

**City:** Olomouc

**Country:** Czechia

**Facility:** MUDr. Gregar, s.r.o.

**Zip:** 779 00

**Location 42:**

**City:** Olomouc

**Country:** Czechia

**Facility:** PreventaMed, s.r.o.

**Zip:** 779 00

**Location 43:**

**City:** Plzen-Lochotin

**Country:** Czechia

**Facility:** I. Interni klinika FN Plzen

**Zip:** 304 60

**Location 44:**

**City:** Slany

**Country:** Czechia

**Facility:** Nemocnice Slaný

**Zip:** 274 01

**Location 45:**

**City:** Grenoble Cedex 09

**Country:** France

**Facility:** CHU De Grenoble Hopital Albert Michallon

**Zip:** 38043

**Location 46:**

**City:** Mont-de-Marsan Cedex

**Country:** France

**Facility:** Centre Hospitalier de Mont de Marsan

**Zip:** 40024

**Location 47:**

**City:** Tbilisi

**Country:** Georgia

**Facility:** Acad. F. Todua Medical Center - Research Institute of Clinical Medicine

**Zip:** 0112

**Location 48:**

**City:** Tbilisi

**Country:** Georgia

**Facility:** Medical Center: Medinvestment

**Zip:** 0186

**Location 49:**

**City:** Budapest

**Country:** Hungary

**Facility:** Clinexpert SMO

**Zip:** 1033

**Location 50:**

**City:** Budapest

**Country:** Hungary

**Facility:** Óbudai Egészségügyi Centrum

**Zip:** 1036

**Location 51:**

**City:** Gyöngyös

**Country:** Hungary

**Facility:** Bugát Pál Kórház

**Zip:** 3200

**Location 52:**

**City:** Szekszard

**Country:** Hungary

**Facility:** CLINFAN Szolgáltató Kft

**Zip:** 7100

**Location 53:**

**City:** Rajkot

**Country:** India

**Facility:** Shree Giriraj Multispeciality Hospital

**State:** Gujarat

**Zip:** 360004

**Location 54:**

**City:** Surat

**Country:** India

**Facility:** Gujarat Hospital - Gastro and Vascular Centre

**State:** Gujarat

**Zip:** 395009

**Location 55:**

**City:** Nagpur

**Country:** India

**Facility:** Kingsway Hospital

**State:** Maharashtra

**Zip:** 440001

**Location 56:**

**City:** Nagpur

**Country:** India

**Facility:** Midas Multispeciality Hospital Pvt.Ltd.

**State:** Maharashtra

**Zip:** 440010

**Location 57:**

**City:** Jaipur

**Country:** India

**Facility:** SR Kalla Memorial Gastro & General Hospital

**State:** Rajasthan

**Zip:** 302006

**Location 58:**

**City:** Chennai

**Country:** India

**Facility:** Apollo Speciality Hospital - Teynampet

**State:** Tamil Nadu

**Zip:** 600035

**Location 59:**

**City:** Chandigarh

**Country:** India

**Facility:** Postgraduate Institute of Medical Education & Research

**Zip:** 160012

**Location 60:**

**City:** Telangana

**Country:** India

**Facility:** Gandhi Hospital

**Zip:** 500003

**Location 61:**

**City:** Beer Sheva

**Country:** Israel

**Facility:** Soroka Medical Center

**Zip:** 8410101

**Location 62:**

**City:** Nahariya

**Country:** Israel

**Facility:** Galilee Medical Center - Internal A

**Zip:** 22100

**Location 63:**

**City:** Rehovot

**Country:** Israel

**Facility:** Kaplan Medical Center

**Zip:** 7610001

**Location 64:**

**City:** Chikushino

**Country:** Japan

**Facility:** Fukuoka University Chikushi Hospital

**State:** Fukuoka

**Location 65:**

**City:** Sapporo-shi

**Country:** Japan

**Facility:** Tokushukai Sapporo Tokushukai Hospital

**State:** Hokkaido

**Zip:** 004 0041

**Location 66:**

**City:** Sapporo

**Country:** Japan

**Facility:** Sapporo Medical University Hospital

**State:** Hokkaido

**Location 67:**

**City:** Osaka-shi

**Country:** Japan

**Facility:** Infusion Clinic

**State:** Osaka-Fu

**Zip:** 530-0011

**Location 68:**

**City:** Fujiidera

**Country:** Japan

**Facility:** Sai Gastroenterologist Proctology

**State:** Osaka

**Zip:** 583-0027

**Location 69:**

**City:** Hamamatsu-shi

**Country:** Japan

**Facility:** Matsuda Hospital

**State:** Shizuoka-Ken

**Zip:** 4328061

**Location 70:**

**City:** Shinjuku-ku

**Country:** Japan

**Facility:** Center Hospital of the National Center for Global Health and Medicine

**State:** Tokyo-To

**Zip:** 162 8655

**Location 71:**

**City:** Koto-ku

**Country:** Japan

**Facility:** Showa University Koto Toyosu Hospital

**State:** Tokyo

**Zip:** 135 8577

**Location 72:**

**City:** Mitaka

**Country:** Japan

**Facility:** Kyorin University Hospital

**State:** Tokyo

**Zip:** 181-8611

**Location 73:**

**City:** Fukuoka

**Country:** Japan

**Facility:** Fukuoka University Hospital

**Zip:** 814-0180

**Location 74:**

**City:** Kagoshima

**Country:** Japan

**Facility:** Sameshima Hospital

**Zip:** 892-0846

**Location 75:**

**City:** Toyama

**Country:** Japan

**Facility:** Toyama Prefectural Central Hospital

**Zip:** 930-8550

**Location 76:**

**City:** Yamagata

**Country:** Japan

**Facility:** Yamagata University Hospital

**Zip:** 990-9585

**Location 77:**

**City:** Suwon-si

**Country:** Korea, Republic of

**Facility:** Ajou University Hospital

**State:** Gyeonggi-do

**Zip:** 443380

**Location 78:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Samsung Medical Center

**State:** Korea

**Zip:** 06351

**Location 79:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul St. Mary's Hospital

**State:** Korea

**Zip:** 06591

**Location 80:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Inje University Haeundae Paik Hospital

**Zip:** 48108

**Location 81:**

**City:** Gangwon-do

**Country:** Korea, Republic of

**Facility:** Yonsei University Wonju Severance Christian Hospital

**Zip:** 26426

**Location 82:**

**City:** Riga

**Country:** Latvia

**Facility:** Pauls Stradins Clinical Univeristy Hospital

**State:** Rīga

**Zip:** LV-1002

**Location 83:**

**City:** Warsaw

**Country:** Poland

**Facility:** NZOZ Vivamed

**State:** Mazowieckie

**Zip:** 03-580

**Location 84:**

**City:** Elblag

**Country:** Poland

**Facility:** Szpital Miejski Sw. Jana Pawla II

**Zip:** 82-300

**Location 85:**

**City:** Warszawa

**Country:** Poland

**Facility:** WIP Warsaw IBD Point Profesor Kierkus

**Zip:** 00-728

**Location 86:**

**City:** Zamosc

**Country:** Poland

**Facility:** ETG Zamość

**Zip:** 22-400

**Location 87:**

**City:** Oradea

**Country:** Romania

**Facility:** SC Pelican SRL

**State:** Bihor

**Zip:** 410469

**Location 88:**

**City:** Bucuresti

**Country:** Romania

**Facility:** SC Med Life SA

**Zip:** 010719

**Location 89:**

**City:** Bucuresti

**Country:** Romania

**Facility:** SC Centrul Medical Sana SRL

**Zip:** 011025

**Location 90:**

**City:** Bucuresti

**Country:** Romania

**Facility:** Spital Clinic Colentina

**Location 91:**

**City:** Cluj-Napoca

**Country:** Romania

**Facility:** Spitalul Clinic Judetean de Urgenta Cluj

**Zip:** 400006

**Location 92:**

**City:** Timisoara

**Country:** Romania

**Facility:** S.C. Materna Care S.R.L.

**Zip:** 300645

**Location 93:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Olla-Med

**State:** Moskva

**Zip:** 105554

**Location 94:**

**City:** Novosibirsk

**Country:** Russian Federation

**Facility:** Novosibirski Gastrocenter

**State:** Novosibirskaya Oblast'

**Zip:** 630007

**Location 95:**

**City:** Rostov-on-Don

**Country:** Russian Federation

**Facility:** Rostov State Medical University

**State:** Rostovskaya Oblast'

**Zip:** 344091

**Location 96:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Open Joint Stock Company Clinical and Diagnostic Center Euromedservice

**Location 97:**

**City:** Omsk

**Country:** Russian Federation

**Facility:** The University Clinic of OSMU

**Zip:** 644050

**Location 98:**

**City:** Saint-Petersburg

**Country:** Russian Federation

**Facility:** SPb SBIH "City Mariinskaya Hospital"

**Zip:** 194104

**Location 99:**

**City:** St. Petersburg

**Country:** Russian Federation

**Facility:** GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

**Zip:** 195067

**Location 100:**

**City:** Banska Bystrica

**Country:** Slovakia

**Facility:** FNsP FDRoosevelta Banska Bystrica

**Zip:** 97517

**Location 101:**

**City:** Kosice

**Country:** Slovakia

**Facility:** ENDOMED s.r.o.

**Zip:** 04013

**Location 102:**

**City:** Kiev

**Country:** Ukraine

**Facility:** Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

**State:** Kyiv

**Zip:** 4050

**Location 103:**

**City:** Lviv

**Country:** Ukraine

**Facility:** Lviv Railway Clinical Hospital

**State:** Lvivska Oblast

**Zip:** 79000

**Location 104:**

**City:** Lviv

**Country:** Ukraine

**Facility:** Lviv Regional Endocrinology Dispensary

**State:** Lvivska Oblast

**Zip:** 79000

**Location 105:**

**City:** Dnipro

**Country:** Ukraine

**Facility:** Medical Center of LLC Medical Center Clinic of Family Medicine

**Location 106:**

**City:** Kyiv

**Country:** Ukraine

**Facility:** International Institute of Clinical Trials LLC

**Zip:** 02091

**Location 107:**

**City:** Odesa

**Country:** Ukraine

**Facility:** Communal Enterprise "Odesa Regional Clinical Hospital"

**Zip:** 65000

**Location 108:**

**City:** Uzhgorod

**Country:** Ukraine

**Facility:** A. Novak Transcarpathian Regional Clinical Hospital

**Zip:** 88018

**Location 109:**

**City:** Vinnytsia

**Country:** Ukraine

**Facility:** CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

**Zip:** 21029

**Location 110:**

**City:** Vinnytsia

**Country:** Ukraine

**Facility:** Vinnytsia War Veterans Regional Clinical Hospital

**Location 111:**

**City:** Zaporizhzhia

**Country:** Ukraine

**Facility:** Diacenter LLC

**Zip:** 69076

**Location 112:**

**City:** Derby

**Country:** United Kingdom

**Facility:** Royal Derby Hospital

**State:** Derbyshire

**Zip:** DE22 3NE

**Location 113:**

**City:** Leytonstone

**Country:** United Kingdom

**Facility:** Whipps Cross University Hospital

**State:** London

**Zip:** E11 1NR

**Location 114:**

**City:** London

**Country:** United Kingdom

**Facility:** Guys/St. Thomas Hospital

**State:** Surrey

**Zip:** SE1 9RT

**Location 115:**

**City:** London

**Country:** United Kingdom

**Facility:** St. George's Hospital

**Zip:** SW17 0QT

**Location 116:**

**City:** York

**Country:** United Kingdom

**Facility:** York Hospital

**Zip:** YO31 8HE

#### Overall Officials

**Official 1:**

**Affiliation:** Nektar Therapeutics

**Name:** Study Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) ( INSTRUCT-UC )

**URL:** https://trials.lillytrialguide.com/en-US/trial/V3FQqG8aJfjj6JtJ60xFt

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-06-03

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 10139127

- Type Abbrev: Prot

- Upload Date: 2023-06-02T07:14

- Date: 2022-03-18

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 1285219

- Type Abbrev: SAP

- Upload Date: 2023-06-02T07:26

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000015212

- Term: Inflammatory Bowel Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6320

- Name: Colitis

- Relevance: HIGH

- As Found: Colitis

- ID: M6321

- Name: Colitis, Ulcerative

- Relevance: HIGH

- As Found: Colitis, Ulcerative

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcerative

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003092

- Term: Colitis

- ID: D000003093

- Term: Colitis, Ulcerative

- ID: D000014456

- Term: Ulcer

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10411

- Name: Interleukin-2

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Removed Countries

- Country: Germany

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All randomized participants who received at least one dose of study drug.

#### Event Groups

**Group ID:** EG000

**Title:** High Dose LY3471851 (Induction Treatment Period)

**Deaths Num At Risk:** 32

**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.

**ID:** EG000

**Other Num Affected:** 20

**Other Num at Risk:** 32

**Serious Number Affected:** 2

**Serious Number At Risk:** 32

**Title:** High Dose LY3471851 (Induction Treatment Period)

**Group ID:** EG001

**Title:** Low Dose LY3471851 (Induction Treatment Period)

**Deaths Num At Risk:** 35

**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.

**ID:** EG001

**Other Num Affected:** 15

**Other Num at Risk:** 35

**Serious Number At Risk:** 35

**Title:** Low Dose LY3471851 (Induction Treatment Period)

**Group ID:** EG002

**Title:** Placebo (Induction Treatment Period)

**Deaths Num At Risk:** 14

**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.

**ID:** EG002

**Other Num Affected:** 5

**Other Num at Risk:** 14

**Serious Number At Risk:** 14

**Title:** Placebo (Induction Treatment Period)

**Group ID:** EG003

**Title:** High Dose LY3471851 (Maintenance Treatment Period)

**Deaths Num At Risk:** 8

**Description:** Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.

**ID:** EG003

**Other Num Affected:** 4

**Other Num at Risk:** 8

**Serious Number At Risk:** 8

**Title:** High Dose LY3471851 (Maintenance Treatment Period)

**Group ID:** EG004

**Title:** Low Dose LY3471851 (Maintenance Treatment Period)

**Deaths Num At Risk:** 10

**Description:** Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.

**ID:** EG004

**Other Num Affected:** 6

**Other Num at Risk:** 10

**Serious Number Affected:** 1

**Serious Number At Risk:** 10

**Title:** Low Dose LY3471851 (Maintenance Treatment Period)

**Group ID:** EG005

**Title:** Placebo (Maintenance Treatment Period)

**Deaths Num At Risk:** 5

**Description:** Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.

**ID:** EG005

**Other Num Affected:** 1

**Other Num at Risk:** 5

**Serious Number At Risk:** 5

**Title:** Placebo (Maintenance Treatment Period)

**Group ID:** EG006

**Title:** High Dose LY3471851 (Extension Treatment Period)

**Deaths Num At Risk:** 26

**Description:** Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.

**ID:** EG006

**Other Num Affected:** 5

**Other Num at Risk:** 26

**Serious Number At Risk:** 26

**Title:** High Dose LY3471851 (Extension Treatment Period)

**Group ID:** EG007

**Title:** High Dose LY3471851 (Post-Treatment Follow-up Period)

**Deaths Num At Risk:** 25

**Description:** Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.

**ID:** EG007

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** High Dose LY3471851 (Post-Treatment Follow-up Period)

**Group ID:** EG008

**Title:** Low Dose LY3471851 (Post-Treatment Follow-up Period)

**Deaths Num At Risk:** 30

**Description:** Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.

**ID:** EG008

**Other Num Affected:** 1

**Other Num at Risk:** 30

**Serious Number Affected:** 1

**Serious Number At Risk:** 30

**Title:** Low Dose LY3471851 (Post-Treatment Follow-up Period)

**Group ID:** EG009

**Title:** Placebo (Post-Treatment Follow-up Period)

**Deaths Num At Risk:** 11

**Description:** Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.

**ID:** EG009

**Other Num Affected:** 1

**Other Num at Risk:** 11

**Serious Number At Risk:** 11

**Title:** Placebo (Post-Treatment Follow-up Period)

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Extrasystoles

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Colitis ulcerative

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Application site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hyperthermia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Influenza like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Injection site reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Covid-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Erysipelas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Tonsillitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Injection related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 25.1

**Term:** Body temperature increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Musculoskeletal stiffness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Acne

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Rosacea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 25.1

#### Serious Events

**Term:** Proctitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 35

**Group ID:** EG002

**Num At Risk:** 14

**Group ID:** EG003

**Num At Risk:** 8

**Group ID:** EG004

**Num At Risk:** 10

**Group ID:** EG005

**Num At Risk:** 5

**Group ID:** EG006

**Num At Risk:** 26

**Group ID:** EG007

**Num At Risk:** 25

**Group ID:** EG008

**Num At Risk:** 30

**Group ID:** EG009

**Num At Risk:** 11

**Term:** Vulval abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 32

**Group ID:** EG001

**Num At Risk:** 35

**Group ID:** EG002

**Num At Risk:** 14

**Group ID:** EG003

**Num At Risk:** 8

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 10

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 5

**Group ID:** EG006

**Num At Risk:** 26

**Group ID:** EG007

**Num At Risk:** 25

**Group ID:** EG008

**Num At Risk:** 30

**Group ID:** EG009

**Num At Risk:** 11

**Term:** Lower limb fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 32

**Group ID:** EG001

**Num At Risk:** 35

**Group ID:** EG002

**Num At Risk:** 14

**Group ID:** EG003

**Num At Risk:** 8

**Group ID:** EG004

**Num At Risk:** 10

**Group ID:** EG005

**Num At Risk:** 5

**Group ID:** EG006

**Num At Risk:** 26

**Group ID:** EG007

**Num At Risk:** 25

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 30

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 11

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 32

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 35

**Group ID:** EG002

**Num At Risk:** 14

**Group ID:** EG003

**Num At Risk:** 8

**Group ID:** EG004

**Num At Risk:** 10

**Group ID:** EG005

**Num At Risk:** 5

**Group ID:** EG006

**Num At Risk:** 26

**Group ID:** EG007

**Num At Risk:** 25

**Group ID:** EG008

**Num At Risk:** 30

**Group ID:** EG009

**Num At Risk:** 11

**Time Frame:** Baseline to Follow-up (Up To Week 58)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 32

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 81

**Units:** Participants

### Group

**ID:** BG000

**Title:** High Dose LY3471851 (Induction Treatment Period)

**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.

### Group

**ID:** BG001

**Title:** Low Dose LY3471851 (Induction Treatment Period)

**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.

### Group

**ID:** BG002

**Title:** Placebo (Induction Treatment Period)

**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.5

**Value:** 39.2

#### Measurement

**Group ID:** BG001

**Spread:** 13.8

**Value:** 44.5

#### Measurement

**Group ID:** BG002

**Spread:** 15.2

**Value:** 45.7

#### Measurement

**Group ID:** BG003

**Spread:** 13.7

**Value:** 42.6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 32

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 81

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 25

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 56

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 32

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 81

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 11

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 12

#### Measurement

**Group ID:** BG003

**Value:** 68

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 32

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 81

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Argentina

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Australia

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Belgium

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Czechia

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Hungary

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Japan

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** South Korea

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Latvia

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Poland

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 13

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Russia

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Slovakia

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 18

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** Ukraine

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 8

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 31

**Group ID:** BG001

**Value:** 35

**Group ID:** BG002

**Value:** 14

**Group ID:** BG003

**Value:** 80

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** All randomized participants with non-missing region of enrollment data.
**Title:** Region of Enrollment
**Unit of Measure:** Participants
**Population Description:** All randomized participants.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** StudyInquiry@nektar.com
**Organization:** Nektar Therapeutics
**Phone:** 855-482-8676
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.03
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 11.32
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.750
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.57
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 6.21
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.838
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.80
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.30
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.563
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.57
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.17
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.64
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.759
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.78
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.93
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.163
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.18
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.11
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.77
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.439
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.54
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.17
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9.88
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.821
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.29
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.37
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.49
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.572
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.43
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.14
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 10.16
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.886
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.18
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.14
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 4.18
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.784
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.78
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.06
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.43
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.331
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.37
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.52
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.407
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.51
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 0.38
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 6.00
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.564
**P-Value Comment:** 
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.50
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.21
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 10.97
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.681
**P-Value Comment:** 
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.51
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -3.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 10.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.317
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 3.6
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -2.3
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 16.1
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.238
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** 6.9
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** -12.17
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 31.60
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.935
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.378
**P-Value Comment:** 
**Parameter Type:** LS Mean Difference
**Parameter Value:** 9.71
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -21.78
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 19.88
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.406
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.928
**P-Value Comment:** 
**Parameter Type:** LS Mean Difference
**Parameter Value:** -0.95
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 10
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 32.6
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 16.7
- **Value:** 7.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 3.5
- **Spread:** 
- **Upper Limit:** 31
- **Value:** 17.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10.6
- **Spread:** 
- **Upper Limit:** 60.8
- **Value:** 35.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21.2
- **Spread:** 
- **Upper Limit:** 57.4
- **Value:** 39.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 23.5
- **Spread:** 
- **Upper Limit:** 59.3
- **Value:** 41.4
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.9
- **Spread:** 
- **Upper Limit:** 52.2
- **Value:** 28.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.3
- **Spread:** 
- **Upper Limit:** 27.2
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 8.6
- **Spread:** 
- **Upper Limit:** 39.7
- **Value:** 24.1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 42.9
- **Value:** 21.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.8
- **Spread:** 
- **Upper Limit:** 49.4
- **Value:** 32.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 20.3
- **Spread:** 
- **Upper Limit:** 55.6
- **Value:** 37.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 42.9
- **Value:** 21.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.8
- **Spread:** 
- **Upper Limit:** 49.4
- **Value:** 32.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 11.3
- **Spread:** 
- **Upper Limit:** 43.9
- **Value:** 27.6
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.9
- **Spread:** 
- **Upper Limit:** 68.8
- **Value:** 42.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.5
- **Spread:** 
- **Upper Limit:** 61.2
- **Value:** 42.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 26.7
- **Spread:** 
- **Upper Limit:** 62.9
- **Value:** 44.8
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 20.6
- **Value:** 7.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 16.7
- **Value:** 7.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 21.4
- **Value:** 10.3
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 0
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 10.4
- **Value:** 3.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 16.1
- **Value:** 6.9
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.346
- **Upper Limit:** 
- **Value:** 26.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.640
- **Upper Limit:** 
- **Value:** 36.42
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.143
- **Upper Limit:** 
- **Value:** 25.76
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 49
- **Upper Limit:** 
- **Value:** 91.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 105
- **Upper Limit:** 
- **Value:** 139
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Clinical Remission at Week 12
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 2
**Description:** Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Clinical Response at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 3
**Description:** Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Endoscopic Remission at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 4
**Description:** Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Endoscopic Response at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 5
**Description:** Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Symptomatic Remission at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 6
**Description:** Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Symptomatic Response at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 7
**Description:** Histologic Remission is defined as Geboes score \<2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=\>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had Geboes data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Histologic Remission at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 8
**Description:** HEMH is defined as Geboes score \<2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=\>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants who received at least one dose of study drug and had Geboes, MMS data at week 12.
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 9
**Description:** IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: \[4 to 6\] or \[7 to 9\]) and region (North America/Europe/Other) as fixed factors.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** All randomized participants who received at least one dose of study drug and had IBDQ data at baseline, week 12.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 12
**Title:** Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Placebo (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG002
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Outcome Measure 10
**Description:** C-trough is the concentration of drug in the blood immediately before the next dose was administered.
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All participants who received at least 1 dose of LY3471851 and had evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Predose at week 12
**Title:** Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12
**Type:** SECONDARY
**Unit of Measure:** microgram per milliliter (µg/mL)
##### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG000
**Title:** Low Dose LY3471851 (Induction Treatment Period)
##### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** OG001
**Title:** High Dose LY3471851 (Induction Treatment Period)
### Participant Flow Module
#### Group
**Description:** Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** FG000
**Title:** High Dose LY3471851 (Induction Treatment Period)
#### Group
**Description:** Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12.
**ID:** FG001
**Title:** Low Dose LY3471851 (Induction Treatment Period)
#### Group
**Description:** Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12.
**ID:** FG002
**Title:** Placebo (Induction Treatment Period)
#### Group
**Description:** Week 12 responders from the high dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
**ID:** FG003
**Title:** High Dose LY3471851 (Maintenance Treatment Period)
#### Group
**Description:** Week 12 responders from the low dose LY3471851 induction treatment period arm entered the maintenance period and continued with the same treatment.
**ID:** FG004
**Title:** Low Dose LY3471851 (Maintenance Treatment Period)
#### Group
**Description:** Week 12 responders from the placebo induction treatment period arm entered the maintenance period and continued with the same treatment.
**ID:** FG005
**Title:** Placebo (Maintenance Treatment Period)
#### Group
**Description:** Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment.
**ID:** FG006
**Title:** High Dose LY3471851 (Extension Treatment Period)
#### Group
**Description:** Participants randomised to high dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
**ID:** FG007
**Title:** High Dose LY3471851 (Post-Treatment Follow-up Period)
#### Group
**Description:** Participants randomised to low dose LY3471851 arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
**ID:** FG008
**Title:** Low Dose LY3471851 (Post-Treatment Follow-up Period)
#### Group
**Description:** Participants randomised to placebo arm entered follow-up period from induction or maintenance, or extension periods and were observed for 6 weeks for safety. No treatments were administered.
**ID:** FG009
**Title:** Placebo (Post-Treatment Follow-up Period)
#### Period
**Title:** Induction Treatment Period
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 11
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** Received at Least One Dose of Study Drug
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
#### Period
**Title:** Maintenance Treatment Period
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 7
###### Reason
**Group ID:** FG004
**Number of Subjects:** 9
###### Reason
**Group ID:** FG005
**Number of Subjects:** 5
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
#### Period
**Title:** Extension Treatment Period
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 6
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 2
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 18
###### Reason
**Group ID:** FG007
**Number of Subjects:** 0
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 26
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 26
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
#### Period
**Title:** Post-Treatment Follow-up Period
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 1
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 2
###### Reason
**Group ID:** FG008
**Number of Subjects:** 3
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 1
###### Reason
**Group ID:** FG008
**Number of Subjects:** 0
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 3
###### Reason
**Group ID:** FG008
**Number of Subjects:** 1
###### Reason
**Group ID:** FG009
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
###### Reason
**Group ID:** FG007
**Number of Subjects:** 18
###### Reason
**Group ID:** FG008
**Number of Subjects:** 26
###### Reason
**Group ID:** FG009
**Number of Subjects:** 11
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 11
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG007
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG008
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG009
**Number of Subjects:** 11
**Pre-Assignment Details:** * (ii) Week 12 non-responders enter the extension period where they received high dose LY3471851. At week 26, those who responded to treatment continued with the same treatment, while non-responders discontinued and entered follow-up.
* a 6-week post-treatment follow-up period: Following treatment completion or discontinuation, participants entered the follow-up period and were observed for safety. No treatments were administered.
**Recruitment Details:** The study consisted of:

* a 12-week induction treatment period: participants randomly received either high dose LY3471851 or low dose LY3471851 or placebo.
* a 40-week maintenance/extension treatment period (final dose at week 50 and study assessments at week 52)
* (i) Week 12 responders enter the maintenance period where they continued to receive the same treatment to which they were randomly assigned.

(Continued..)
**Has Results:** True