Study of Novel Therapeutics for Acute Remedy of Colitis

NCT06420492 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025P001885
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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 8 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

Ulcerative Colitis; Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe

Outcome Measures

Primary Outcomes (1)

• Sulfur Metabolism

  The primary measure of dose response will be urinary measures of sulfur metabolism including a \> 50% reduction from pretreatment levels sulfate, and thiosulfate.

  4 weeks

Secondary Outcomes (8)

• Simple Clinical Colitis Activity Index (SCCAI)

  12 weeks

• Plasma nitrite, nitrate, or nitrosothiol

  8 weeks

• Normalization of fecal calprotectin lab measurements

  8 weeks

• Reduction in fecal calprotectin lab measurements

  4 weeks

• Mayo Score

  4 weeks

Study Arms (1)

BRS201 Arm

EXPERIMENTAL

In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g 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 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. Subjects in Group 4 will undergo two flexible sigmoidoscopies, one at screening and one at week 4.

Drug: BRS201

Interventions

BRS201 DRUG

Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.

BRS201 Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with primary sclerosing cholangitis are eligible to enroll
• Patients will have failed 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \> 6
• Patients who are taking 20mg or less of oral prednisone and plan to stay at that dose during their participation in the study
• Accepted medications:
• Anti-TNF agents are permissible if the patient has been taking them for at least 10 weeks and anticipates to maintain a steady for the duration of the study.
• Rinvoq (Upadacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.
• Xeljanz (Tofacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.
• Other biologics are permissible if the subject has been taking the medication for at least 10 weeks and anticipates to maintain a steady dose for the duration of the study

You may not qualify if:

• History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90
• Chronic kidney disease as defined by GFR \<55mL/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:
• Rinvoq (Upadacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

NOT YET RECRUITING

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Joshua Korzenik, MD

CONTACT

617 732-6389; jkorzenik@bwh.harvard.edu

Siani Ellis

CONTACT

617-396-7703; sellis13@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-Director, Brigham and Women's Hospital Crohn's and Colitis Center

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

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 20, 2024
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (2)