RecruitingPhase 2NCT06420492

Study of Novel Therapeutics for Acute Remedy of Colitis


Sponsor

Brigham and Women's Hospital

Enrollment

20 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new treatments for people having a severe flare of ulcerative colitis (UC) — a condition where the lining of the large intestine becomes dangerously inflamed — who have not responded to steroid treatment. **You may be eligible if...** - You have had a confirmed UC diagnosis for over 3 months with significant colon involvement - You are experiencing a severe flare (SCCAI score above 6) - You have already tried oral steroids for at least 5 days without enough improvement - You are able to give consent - Certain existing UC medications may be allowed if you've been on them long enough **You may NOT be eligible if...** - You do not have confirmed UC (e.g., Crohn's disease or other colitis) - You have active infections like C. difficile - You have serious kidney, liver, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBRS201

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


Locations(2)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

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NCT06420492


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