## Protocol Section
### Identification Module
**NCT ID:** NCT04947579

**Acronym:** AS SpA axSpA

**Brief Title:** A Study of CC-99677 in Participants With Active Ankylosing Spondylitis

**Official Title:** A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis

#### Organization Study ID Info
**ID:** CC-99677-AS-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
#### Secondary ID Infos
**Domain:** UTN Number
**ID:** U1111-1265-3951
**Type:** REGISTRY
**ID:** 2019-004108-37
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2023-02-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-03

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2023-02-21

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Results First Submit Date:** 2024-02-21

**Results First Submit QC Date:** 2024-04-03

#### Start Date
**Date:** 2021-08-25

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2021-07-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-23
**Study First Submit QC Date:** 2021-06-23
**Why Stopped:** The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Celgene

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.

### Conditions Module

**Conditions:**

- Spondylitis, Ankylosing

**Keywords:**

- Ankylosing Spondylitis

- CC-99677

- MK2inhibitor

- Spinal Diseases

- Bone Diseases

- Musculoskeletal Diseases

- Arthritis

- Joint Diseases

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 167

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 49 participants will be randomized to CC-99677 150 mg in biologic naive main study

**Intervention Names:**

- Drug: CC-99677

**Label:** Administration of CC-99677 150 mg QD PO

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 49 participants will be randomized to CC-99677 60 mg in biologic naive main study

**Intervention Names:**

- Drug: CC-99677

**Label:** Administration of CC-99677 60mg QD PO

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 49 participants will be randomized to placebo in biologic naive main study

**Intervention Names:**

- Other: Placebo

**Label:** Administration of Placebo QD PO

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** 20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy

**Intervention Names:**

- Drug: CC-99677

**Label:** Administration of CC-99677 150 mg QD PO.

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** 20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy

**Intervention Names:**

- Drug: CC-99677

**Label:** Administration of CC-99677 60mg QD PO.

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** 10 participants will be randomized to placebo in biologic-failure substudy

**Intervention Names:**

- Other: Placebo

**Label:** Placebo additional dose cohort

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Administration of CC-99677 150 mg QD PO

- Administration of CC-99677 150 mg QD PO.

- Administration of CC-99677 60mg QD PO

- Administration of CC-99677 60mg QD PO.

**Description:** Oral

**Name:** CC-99677

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Administration of Placebo QD PO

- Placebo additional dose cohort

**Description:** Oral

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:

* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).

**Measure:** Percentage of Participants Who Achieve ASAS 20 at Week 12

**Time Frame:** Week 12

#### Secondary Outcomes

**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:

* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).

**Measure:** Percentage of Participants Who Achieve ASAS 40 at Week 12

**Time Frame:** Week 12

**Description:** ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: \<1.3 inactive disease, ≥1.3 and \<2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)

**Measure:** Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12

**Time Frame:** Baseline and Week 12

**Description:** Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.

**Measure:** Change From Baseline in BASDAI at Week 12

**Time Frame:** Baseline and Week 12

**Description:** Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.

**Measure:** Change From Baseline in BASFI at Week 12

**Time Frame:** Baseline and Week 12

**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.

**Measure:** Change From Baseline in the SPARCC SI Joint Score at Week 12

**Time Frame:** Baseline and Week 12

**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.

Baseline is the last non-missing value on or before the date of the first dose of investigational product.

**Measure:** Change From Baseline in the SPARCC Spine Score at Week 12

**Time Frame:** Baseline and Week 12

**Description:** Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.

**Measure:** Percent Change From Baseline in hsCRP at Week 12

**Time Frame:** Baseline and Week 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria
* Active axial disease at Screening and Baseline defined by a Bath Ankylosing
* Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4
* Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each
* Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody \[mAb\] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS

Exclusion Criteria:

* Radiographic evidence of total ankylosis of the spine
* Clinically significant back pain caused by diseases other than AS
* Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents
* Participation in any study of an investigational drug, including those for COVID-19
* History of malignancy
* Oral corticosteroids (prednisone or equivalent) \> 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Flagstaff

**Country:** United States

**Facility:** Local Institution - 024

**State:** Arizona

**Zip:** 86001

**Location 2:**

**City:** Gilbert

**Country:** United States

**Facility:** Local Institution - 021

**State:** Arizona

**Zip:** 58297

**Location 3:**

**City:** Phoenix

**Country:** United States

**Facility:** Local Institution - 022

**State:** Arizona

**Zip:** 95037

**Location 4:**

**City:** Tucson

**Country:** United States

**Facility:** Local Institution - 025

**State:** Arizona

**Zip:** 85704

**Location 5:**

**City:** Tustin

**Country:** United States

**Facility:** Local Institution - 017

**State:** California

**Zip:** 92780

**Location 6:**

**City:** Saint Clair Shores

**Country:** United States

**Facility:** Local Institution - 026

**State:** Michigan

**Zip:** 48081

**Location 7:**

**City:** Cleveland

**Country:** United States

**Facility:** Local Institution - 028

**State:** Ohio

**Zip:** 44106

**Location 8:**

**City:** Dayton

**Country:** United States

**Facility:** Local Institution - 004

**State:** Ohio

**Zip:** 45417

**Location 9:**

**City:** Portland

**Country:** United States

**Facility:** Local Institution - 009

**State:** Oregon

**Zip:** 97239

**Location 10:**

**City:** Duncansville

**Country:** United States

**Facility:** Local Institution - 003

**State:** Pennsylvania

**Zip:** 16635

**Location 11:**

**City:** Jackson

**Country:** United States

**Facility:** Local Institution - 005

**State:** Tennessee

**Zip:** 38305

**Location 12:**

**City:** Memphis

**Country:** United States

**Facility:** Local Institution - 002

**State:** Tennessee

**Zip:** 38119

**Location 13:**

**City:** Austin

**Country:** United States

**Facility:** Local Institution - 029

**State:** Texas

**Zip:** 78731

**Location 14:**

**City:** Colleyville

**Country:** United States

**Facility:** Local Institution - 006

**State:** Texas

**Zip:** 76034

**Location 15:**

**City:** Fort Worth

**Country:** United States

**Facility:** Local Institution - 019

**State:** Texas

**Zip:** 76107

**Location 16:**

**City:** Houston

**Country:** United States

**Facility:** Local Institution - 008

**State:** Texas

**Zip:** 77099

**Location 17:**

**City:** Shanghai

**Country:** China

**Facility:** Local Institution - 154

**State:** Shanghai

**Zip:** 200040

**Location 18:**

**City:** Guangzhou

**Country:** China

**Facility:** Local Institution - 151

**Zip:** 510630

**Location 19:**

**City:** Hangzhou

**Country:** China

**Facility:** Local Institution - 152

**Zip:** 310014

**Location 20:**

**City:** Huangpu District

**Country:** China

**Facility:** Local Institution - 153

**Zip:** 200000

**Location 21:**

**City:** Wuhan

**Country:** China

**Facility:** Local Institution - 150

**Zip:** 430030

**Location 22:**

**City:** Brno

**Country:** Czechia

**Facility:** Local Institution - 205

**Zip:** 61141

**Location 23:**

**City:** Ostrava

**Country:** Czechia

**Facility:** Local Institution - 206

**Zip:** 702 00

**Location 24:**

**City:** Ostrava

**Country:** Czechia

**Facility:** Local Institution - 207

**Zip:** 702 00

**Location 25:**

**City:** Pardubice

**Country:** Czechia

**Facility:** Local Institution - 201

**Zip:** 530 02

**Location 26:**

**City:** Praha 11

**Country:** Czechia

**Facility:** Local Institution - 211

**Zip:** 148 00

**Location 27:**

**City:** Praha 3

**Country:** Czechia

**Facility:** Local Institution - 202

**Zip:** 13000

**Location 28:**

**City:** Praha 4

**Country:** Czechia

**Facility:** Local Institution - 203

**Zip:** 140 00

**Location 29:**

**City:** Uherské Hradište

**Country:** Czechia

**Facility:** Local Institution - 204

**Zip:** 686 01

**Location 30:**

**City:** Herne

**Country:** Germany

**Facility:** Local Institution - 900

**Zip:** 44649

**Location 31:**

**City:** Bialystok

**Country:** Poland

**Facility:** Local Institution - 311

**Zip:** 15-077

**Location 32:**

**City:** Bialystok

**Country:** Poland

**Facility:** Local Institution - 315

**Zip:** 15-351

**Location 33:**

**City:** Bydgoszcz

**Country:** Poland

**Facility:** Local Institution - 305

**Zip:** 85-065

**Location 34:**

**City:** Bydgoszcz

**Country:** Poland

**Facility:** Local Institution - 302

**Zip:** 85-168

**Location 35:**

**City:** Elblag

**Country:** Poland

**Facility:** Local Institution - 301

**Zip:** 82-300

**Location 36:**

**City:** Katowice

**Country:** Poland

**Facility:** Local Institution - 307

**Zip:** 40-282

**Location 37:**

**City:** Krakow

**Country:** Poland

**Facility:** Local Institution - 300

**Zip:** 30-002

**Location 38:**

**City:** Krakow

**Country:** Poland

**Facility:** Local Institution - 308

**Zip:** 30-363

**Location 39:**

**City:** Nowa Sol

**Country:** Poland

**Facility:** Local Institution - 310

**Zip:** 67-100

**Location 40:**

**City:** Onyksowa 10

**Country:** Poland

**Facility:** Local Institution - 313

**Zip:** 20-582

**Location 41:**

**City:** Sochaczew

**Country:** Poland

**Facility:** Local Institution - 312

**Zip:** 96-500

**Location 42:**

**City:** Torun

**Country:** Poland

**Facility:** Local Institution - 306

**Zip:** 87-100

**Location 43:**

**City:** Warsaw

**Country:** Poland

**Facility:** Local Institution - 303

**Zip:** 02-691

**Location 44:**

**City:** Wroclaw

**Country:** Poland

**Facility:** Local Institution - 309

**Zip:** 52-416

**Location 45:**

**City:** Brasov

**Country:** Romania

**Facility:** Local Institution - 400

**Zip:** 500283

**Location 46:**

**City:** Bucuresti

**Country:** Romania

**Facility:** Local Institution - 404

**Zip:** 011025

**Location 47:**

**City:** Bucuresti

**Country:** Romania

**Facility:** Local Institution - 402

**Zip:** 011172

**Location 48:**

**City:** Bucuresti

**Country:** Romania

**Facility:** Local Institution - 403

**Zip:** 011172

**Location 49:**

**City:** A Coruña

**Country:** Spain

**Facility:** Local Institution - 604

**Zip:** 15006

**Location 50:**

**City:** Barcelona

**Country:** Spain

**Facility:** Local Institution - 607

**Zip:** 08035

**Location 51:**

**City:** Cordoba

**Country:** Spain

**Facility:** Local Institution - 606

**Zip:** 14001

**Location 52:**

**City:** Merida

**Country:** Spain

**Facility:** Local Institution - 605

**Zip:** 06800

**Location 53:**

**City:** Sabadell

**Country:** Spain

**Facility:** Local Institution - 601

**Zip:** 8208

**Location 54:**

**City:** Santiago De Compostela

**Country:** Spain

**Facility:** Local Institution - 602

**Zip:** 15706

**Location 55:**

**City:** Sevilla

**Country:** Spain

**Facility:** Local Institution - 603

**Zip:** 41013

**Location 56:**

**City:** Adapazari

**Country:** Turkey

**Facility:** Local Institution - 702

**Zip:** 54100

**Location 57:**

**City:** Altındağ/Ankara

**Country:** Turkey

**Facility:** Local Institution - 707

**Zip:** 06230

**Location 58:**

**City:** Ankara

**Country:** Turkey

**Facility:** Local Institution - 700

**Zip:** 06100

**Location 59:**

**City:** Edirne

**Country:** Turkey

**Facility:** Local Institution - 701

**Zip:** 22030

**Location 60:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Local Institution - 705

**Zip:** 34098

**Location 61:**

**City:** Izmir

**Country:** Turkey

**Facility:** Local Institution - 706

**Zip:** 35100

**Location 62:**

**City:** Karabaglar

**Country:** Turkey

**Facility:** Local Institution - 704

**Zip:** 35360

**Location 63:**

**City:** Trabzon

**Country:** Turkey

**Facility:** Local Institution - 703

**Zip:** 61080

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** See Plan Description

**Description:** Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** See Plan Description

**URL:** https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** FDA Safety Alerts and Recalls

**URL:** http://www.fda.gov/safety/medwatch/safetyinformation/default.htm

**Label:** BMS Clinical Trial Patient Recruiting

**URL:** https://www.BMSStudyConnect.com

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-09-21

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 4895769

- Type Abbrev: Prot_SAP

- Upload Date: 2024-02-21T10:02

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001850

- Term: Bone Diseases, Infectious

- ID: D000007239

- Term: Infections

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000089183

- Term: Axial Spondyloarthritis

- ID: D000025242

- Term: Spondylarthropathies

- ID: D000000844

- Term: Ankylosis

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15961

- Name: Spondylitis

- Relevance: HIGH

- As Found: Spondylitis

- ID: M23035

- Name: Spondylarthritis

- Relevance: HIGH

- As Found: Spondylitis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15962

- Name: Spondylitis, Ankylosing

- Relevance: HIGH

- As Found: Spondylitis, Ankylosing

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5129

- Name: Bone Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M2697

- Name: Axial Spondyloarthritis

- Relevance: LOW

- As Found: Unknown

- ID: M23036

- Name: Spondylarthropathies

- Relevance: LOW

- As Found: Unknown

- ID: M4170

- Name: Ankylosis

- Relevance: LOW

- As Found: Unknown

- ID: T5412

- Name: Spondylarthropathy

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013166

- Term: Spondylitis

- ID: D000025241

- Term: Spondylarthritis

- ID: D000013167

- Term: Spondylitis, Ankylosing

### Misc Info Module

#### Removed Countries

- Country: Canada

- Country: Russian Federation

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2024-03-21

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.

#### Event Groups

**Group ID:** EG000

**Title:** CC-99677 150 mg Biologic Naive

**Deaths Num At Risk:** 49

**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation

**ID:** EG000

**Other Num Affected:** 11

**Other Num at Risk:** 49

**Serious Number At Risk:** 49

**Title:** CC-99677 150 mg Biologic Naive

**Group ID:** EG001

**Title:** CC-99677 60 mg Biologic Naive

**Deaths Num At Risk:** 49

**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation

**ID:** EG001

**Other Num Affected:** 26

**Other Num at Risk:** 49

**Serious Number At Risk:** 49

**Title:** CC-99677 60 mg Biologic Naive

**Group ID:** EG002

**Title:** Placebo Biologic Naive

**Deaths Num At Risk:** 7

**Description:** Placebo Biologic Naive QD PO from week 0 - 12

**ID:** EG002

**Other Num at Risk:** 7

**Serious Number Affected:** 1

**Serious Number At Risk:** 7

**Title:** Placebo Biologic Naive

**Group ID:** EG003

**Title:** Placebo to CC-99677 150 mg Biologic Naive

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 21

**Description:** At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation

**ID:** EG003

**Other Num Affected:** 8

**Other Num at Risk:** 21

**Serious Number Affected:** 3

**Serious Number At Risk:** 21

**Title:** Placebo to CC-99677 150 mg Biologic Naive

**Group ID:** EG004

**Title:** Placebo to CC-99677 60 mg Biologic Naive

**Deaths Num At Risk:** 21

**Description:** At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation

**ID:** EG004

**Other Num Affected:** 7

**Other Num at Risk:** 21

**Serious Number At Risk:** 21

**Title:** Placebo to CC-99677 60 mg Biologic Naive

**Group ID:** EG005

**Title:** CC-99677 150 mg Biologic Failure

**Deaths Num At Risk:** 8

**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation

**ID:** EG005

**Other Num Affected:** 6

**Other Num at Risk:** 8

**Serious Number Affected:** 3

**Serious Number At Risk:** 8

**Title:** CC-99677 150 mg Biologic Failure

**Group ID:** EG006

**Title:** CC-99677 60 mg Biologic Failure

**Deaths Num At Risk:** 7

**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation

**ID:** EG006

**Other Num Affected:** 4

**Other Num at Risk:** 7

**Serious Number At Risk:** 7

**Title:** CC-99677 60 mg Biologic Failure

**Group ID:** EG007

**Title:** Placebo Biologic Failure

**Deaths Num At Risk:** 2

**Description:** Placebo Biologic Failure QD PO from week 0 - 12

**ID:** EG007

**Other Num Affected:** 1

**Other Num at Risk:** 2

**Serious Number Affected:** 1

**Serious Number At Risk:** 2

**Title:** Placebo Biologic Failure

**Group ID:** EG008

**Title:** Placebo to CC-99677 150 mg Biologic Failure

**Deaths Num At Risk:** 1

**Description:** At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation

**ID:** EG008

**Other Num Affected:** 1

**Other Num at Risk:** 1

**Serious Number At Risk:** 1

**Title:** Placebo to CC-99677 150 mg Biologic Failure

**Group ID:** EG009

**Title:** Placebo to CC-99677 60 mg Biologic Failure

**Deaths Num At Risk:** 2

**Description:** At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation

**ID:** EG009

**Other Num Affected:** 1

**Other Num at Risk:** 2

**Serious Number At Risk:** 2

**Title:** Placebo to CC-99677 60 mg Biologic Failure

**Frequency Threshold:** 5

#### Other Events

**Term:** Lymphadenopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Iridocyclitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Swelling of eyelid

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Aphthous ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal 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:** Genital candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Gingivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Laryngitis

**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:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Otitis media

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Pharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Pulpitis dental

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Rhinitis

**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:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Viral infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Viral upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Head injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Rib fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Electrocardiogram QT prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Transaminases increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Ankylosing spondylitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Radiculopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Depressed mood

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Renal colic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

#### Serious Events

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Colitis ulcerative

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 7

**Group ID:** EG003

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Oral candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Clavicle fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Concussion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Road traffic accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Metastases to peritoneum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Term:** Psychotic disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 49

**Group ID:** EG002

**Num At Risk:** 7

**Group ID:** EG003

**Num At Risk:** 21

**Group ID:** EG004

**Num At Risk:** 21

**Group ID:** EG005

**Num At Risk:** 8

**Group ID:** EG006

**Num At Risk:** 7

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 2

**Group ID:** EG008

**Num At Risk:** 1

**Group ID:** EG009

**Num At Risk:** 2

**Time Frame:** Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 49

**Group ID:** BG002

**Value:** 49

**Group ID:** BG003

**Value:** 5

**Group ID:** BG004

**Value:** 7

**Group ID:** BG005

**Value:** 8

**Group ID:** BG006

**Value:** 167

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo Biologic Naive

**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation

### Group

**ID:** BG001

**Title:** CC-99677 60 mg Biologic Naive

**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation

### Group

**ID:** BG002

**Title:** CC-99677 150 mg Biologic Naive

**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation

### Group

**ID:** BG003

**Title:** Placebo Biologic Failure

**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation

### Group

**ID:** BG004

**Title:** CC-99677 60 mg Biologic Failure

**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation

### Group

**ID:** BG005

**Title:** CC-99677 150 mg Biologic Failure

**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation

### Group

**ID:** BG006

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.27

**Value:** 44.1

#### Measurement

**Group ID:** BG001

**Spread:** 11.78

**Value:** 40.5

#### Measurement

**Group ID:** BG002

**Spread:** 9.75

**Value:** 40.4

#### Measurement

**Group ID:** BG003

**Spread:** 7.16

**Value:** 43.8

#### Measurement

**Group ID:** BG004

**Spread:** 10.06

**Value:** 44.4

#### Measurement

**Group ID:** BG005

**Spread:** 9.46

**Value:** 42.5

#### Measurement

**Group ID:** BG006

**Spread:** 10.48

**Value:** 41.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 12

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 43

#### Measurement

**Group ID:** BG002

**Value:** 37

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 6

#### Measurement

**Group ID:** BG005

**Value:** 8

#### Measurement

**Group ID:** BG006

**Value:** 139

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 4

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 47

#### Measurement

**Group ID:** BG001

**Value:** 47

#### Measurement

**Group ID:** BG002

**Value:** 49

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 7

#### Measurement

**Group ID:** BG005

**Value:** 8

#### Measurement

**Group ID:** BG006

**Value:** 163

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 1

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

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 2

**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

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 48

#### Measurement

**Group ID:** BG001

**Value:** 48

#### Measurement

**Group ID:** BG002

**Value:** 48

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 7

#### Measurement

**Group ID:** BG005

**Value:** 8

#### Measurement

**Group ID:** BG006

**Value:** 164

**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

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**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

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**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:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** Clinical.Trials@bms.com
**Organization:** Bristol-Myers Squibb
**Phone:** Please Email
**Title:** Bristol-Myers Squibb Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -18.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 22.7
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.829
**P-Value Comment:** 
**Parameter Type:** Stratified difference
**Parameter Value:** 2.4
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -13.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 27.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.512
**P-Value Comment:** 
**Parameter Type:** Stratified difference
**Parameter Value:** 7.3
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -14.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 21.0
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.725
**P-Value Comment:** 
**Parameter Type:** Stratified difference
**Parameter Value:** 3.3
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -7.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 30.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.219
**P-Value Comment:** 
**Parameter Type:** Stratfied difference
**Parameter Value:** 12.2
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.50
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.16
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.167
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.299
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.17
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.45
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.22
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.168
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.488
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.12
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.76
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.79
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.391
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.970
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.01
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.95
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.61
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.393
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.668
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.17
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.88
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.416
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.890
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.06
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.57
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.08
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.417
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.545
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.25
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -2.26
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.70
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.999
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.778
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.28
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -3.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.03
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.022
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.330
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.00
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -3.93
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.28
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.567
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.600
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.82
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -4.49
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.87
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.605
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.416
**P-Value Comment:** 
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.31
**Statistical Comment:** 
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -27.31
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 14.79
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.741
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Adjusted Mean
**Parameter Value:** -6.26
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -36.57
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.58
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.181
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Adjusted Mean
**Parameter Value:** -18.58
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -31.96
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.65
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.105
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Adjusted Mean
**Parameter Value:** -12.16
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.7
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83.3
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.3
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.856
- **Upper Limit:** 
- **Value:** -0.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.681
- **Upper Limit:** 
- **Value:** -0.87
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.869
- **Upper Limit:** 
- **Value:** -0.80
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.621
- **Upper Limit:** 
- **Value:** -0.84
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.464
- **Upper Limit:** 
- **Value:** -1.02
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 0.323
- **Upper Limit:** 
- **Value:** -0.44
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.862
- **Upper Limit:** 
- **Value:** -1.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.494
- **Upper Limit:** 
- **Value:** -1.96
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.080
- **Upper Limit:** 
- **Value:** -2.03
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.651
- **Upper Limit:** 
- **Value:** -1.63
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.394
- **Upper Limit:** 
- **Value:** -2.20
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 1.517
- **Upper Limit:** 
- **Value:** -1.43
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.727
- **Upper Limit:** 
- **Value:** -1.22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.985
- **Upper Limit:** 
- **Value:** -1.33
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.542
- **Upper Limit:** 
- **Value:** -1.28
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.850
- **Upper Limit:** 
- **Value:** -1.77
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.841
- **Upper Limit:** 
- **Value:** -1.47
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 0.703
- **Upper Limit:** 
- **Value:** -1.29
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.168
- **Upper Limit:** 
- **Value:** 0.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.453
- **Upper Limit:** 
- **Value:** -0.81
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 6.084
- **Upper Limit:** 
- **Value:** -1.72
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 1.258
- **Upper Limit:** 
- **Value:** -0.17
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 7.608
- **Upper Limit:** 
- **Value:** -3.00
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 4.093
- **Upper Limit:** 
- **Value:** -3.00
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.557
- **Upper Limit:** 
- **Value:** -0.92
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.331
- **Upper Limit:** 
- **Value:** -1.53
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.081
- **Upper Limit:** 
- **Value:** -1.86
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 7.371
- **Upper Limit:** 
- **Value:** -8.17
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 5.128
- **Upper Limit:** 
- **Value:** -2.40
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 8.640
- **Upper Limit:** 
- **Value:** -2.71
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 474.199
- **Upper Limit:** 
- **Value:** 72.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 64.157
- **Upper Limit:** 
- **Value:** -1.43
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 130.181
- **Upper Limit:** 
- **Value:** 20.88
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 55.618
- **Upper Limit:** 
- **Value:** -13.68
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 66.057
- **Upper Limit:** 
- **Value:** 8.52
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 1226.664
- **Upper Limit:** 
- **Value:** 452.34
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:

* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
**Parameter Type:** NUMBER
**Population Description:** All treated participants who have non-missing response at week 12
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieve ASAS 20 at Week 12
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 2
**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:

* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
**Parameter Type:** NUMBER
**Population Description:** All treated participants who have non-missing response at week 12
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieve ASAS 40 at Week 12
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 3
**Description:** ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: \<1.3 inactive disease, ≥1.3 and \<2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 4
**Description:** Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in BASDAI at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 5
**Description:** Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in BASFI at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 6
**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in the SPARCC SI Joint Score at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 7
**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.

Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in the SPARCC Spine Score at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 8
**Description:** Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Percent Change From Baseline in hsCRP at Week 12
**Type:** SECONDARY
**Unit of Measure:** Percent change in hsCRP
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
### Participant Flow Module
#### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** FG000
**Title:** Placebo Biologic Naive
#### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** FG001
**Title:** CC-99677 60 mg Biologic Naive
#### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** FG002
**Title:** CC-99677 150 mg Biologic Naive
#### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** FG003
**Title:** Placebo Biologic Failure
#### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** FG004
**Title:** CC-99677 60 mg Biologic Failure
#### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** FG005
**Title:** CC-99677 150 mg Biologic Failure
#### Period
**Title:** Week 0 - Week 12 (Placebo-Controlled)
##### 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:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Other reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### 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
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 7
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Deviation
###### 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
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 8
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 7
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 1
#### Period
**Title:** Week 12 - Week 64 (Long-Term Extension)
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### 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
##### Withdraw
**Type:** Adverse Event
###### 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:** 1
##### 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:** 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
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 54
###### Reason
**Group ID:** FG002
**Number of Subjects:** 46
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 5
###### Reason
**Group ID:** FG005
**Number of Subjects:** 4
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 4
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 3
##### Withdraw
**Type:** Other reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 63
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 8
##### Milestone
**Type:** Placebo Patients Re-randomized to CC-99677 60 mg
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** Placebo Patients Re-randomized to CC-99677 150 mg
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 1
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 62
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 60
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 8
**Pre-Assignment Details:** Participants originally randomized to the CC-99677 60 mg or 150 mg Biologic Naive or Biologic Failure arms in the Placebo-Controlled period continued receiving the same intervention until week 64 in the Long-Term Extension period.
**Has Results:** True