## Protocol Section
### Identification Module
**NCT ID:** NCT06420492

**Acronym:** SHARC

**Brief Title:** Study of Novel Therapeutics for Acute Remedy of Colitis

**Official Title:** Study of Novel Therapeutics for Acute Remedy of Colitis

#### Organization Study ID Info
**ID:** Unknown (Pending approval)
#### Organization
**Class:** OTHER
**Full Name:** Brigham and Women's Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Brigham and Women's Hospital

#### Responsible Party

**Investigator Affiliation:** Brigham and Women's Hospital

**Investigator Full Name:** Joshua Korzenik

**Investigator Title:** MD-Director, Brigham and Women's Hospital Crohn's and Colitis Center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.

### Conditions Module

**Conditions:**

- Ulcerative Colitis

- Ulcerative Colitis Chronic Moderate

- Ulcerative Colitis Chronic Severe

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** This is an open-label study in which everyone will receive active treatment.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In Group 1 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.

In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation.

In Group 3 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive one 2.5g dose of study drug at initiation and a second 2.5g intravenous dose of study drug at week 2.

**Intervention Names:**

- Drug: BRS201

**Label:** BRS201 Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BRS201 Arm

**Description:** Groups 1, 2, and 3 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.

**Name:** BRS201

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The primary endpoint for this study is change in Total Mayo Score with improvement being a reduction in 3 points and remission being a score of 0 or 1 from day 0 to end of week 4 (at second flexible sigmoidoscopy).

**Measure:** Mayo Score

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** Clinical symptoms assessed by SCCAI which measures patient reported outcomes on a scale of 0 to 19, where a higher score indicates more severe activity and active disease is a score of 5 or more.

**Measure:** Simple Clinical Colitis Activity Index (SCCAI)

**Time Frame:** 12 weeks

**Description:** Correlation between changes in plasma nitrite, nitrate or nitrosothiol level in relation to calprotectin

**Measure:** Plasma nitrite, nitrate, or nitrosothiol

**Time Frame:** 8 weeks

**Description:** The capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks) and at week 6.

**Measure:** Normalization of fecal calprotectin lab measurements

**Time Frame:** 8 weeks

**Description:** Reduction in fecal calprotectin to \< ULN at the end of active treatment

**Measure:** Reduction in fecal calprotectin lab measurements

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Severe outpatient or hospitalized for an acute UC flare
* Ability to give consent
* Patients with a confirmed diagnosis of UC for \> 3 months
* History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy
* Total Mayo score of \> 6
* Patients with primary sclerosing cholangitis are eligible to enroll
* Patients will have failed 3 days of IV steroids or 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \> 6
* Anticipated to be administered ustekinumab, vedolizumab or 6-MP/azathioprine as their subsequent medication.

Exclusion Criteria:

* History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90
* Chronic kidney disease as defined by GFR \<60mL/min
* Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC
* Evidence of C. difficile (Negative test result within 1 month is acceptable)
* Infectious Colitis or drug induced colitis
* Crohn's Disease or Indeterminate colitis
* Decompensated liver disease
* Patients who are pregnant or breastfeeding
* Patients who have a confirmed malignancy or cancer within 5 years
* Congenital or acquired immunodeficiencies
* Other comorbidities including: Diabetes mellitus, systemic lupus
* Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
* Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
* Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks
* Patients are planned to be started on a fast- acting medication including an anti-TNF agent (infliximab, adalimumab, golimumab, certolizumab), on a JAKi (upadacitinib, tofacitinib)

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jkorzenik@bwh.harvard.edu

**Name:** Joshua Korzenik, MD

**Phone:** 617 732-6389

**Role:** CONTACT

**Contact 2:**

**Email:** sellis13@bwh.harvard.edu

**Name:** Siani Ellis

**Phone:** 617-396-7703

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chestnut Hill

**Contacts:**

***Contact 1:***

- **Email:** sellis13@bwh.harvard.edu

- **Name:** Siani Ellis

- **Phone:** 617-396-7703

- **Role:** CONTACT

***Contact 2:***

- **Email:** smitchell22@bwh.harvard.edu

- **Name:** Sophie Mitchell

- **Role:** CONTACT

***Contact 3:***

- **Name:** Joshua Korzenik, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Brigham and Women's Hospital

**State:** Massachusetts

**Zip:** 02467

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000015212

- Term: Inflammatory Bowel Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulcerative

- ID: M6320

- Name: Colitis

- Relevance: HIGH

- As Found: Colitis

- ID: M6321

- Name: Colitis, Ulcerative

- Relevance: HIGH

- As Found: Ulcerative Colitis

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003092

- Term: Colitis

- ID: D000003093

- Term: Colitis, Ulcerative

- ID: D000014456

- Term: Ulcer

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6263

- Name: Coal Tar

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
