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RecruitingPhase 2NCT06420375

Treatment of UC With Novel Therapeutics

Treatment of Ulcerative Colitis With Novel Therapeutics

Sponsor

Brigham and Women's Hospital

Enrollment

20 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative ColitisUlcerative Colitis Mild

Summary

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new treatments for ulcerative colitis (UC), a condition where the lining of the large intestine becomes inflamed, causing diarrhea, bleeding, and abdominal pain. The study focuses on patients whose UC has been confirmed for at least 3 months with significant colon involvement. **You may be eligible if...** - You have had a confirmed UC diagnosis for more than 3 months - Colonoscopy confirms at least 15 cm of colon involvement - Your inflammation marker (calprotectin) is above 200 - You can give consent - You may also be eligible if you have primary sclerosing cholangitis (a liver condition linked to UC) **You may NOT be eligible if...** - You have uncontrolled high blood pressure - You have significant kidney or liver problems - You have active C. difficile infection, Crohn's disease, or drug-induced colitis - You have advanced liver disease 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 and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.

DRUGPlacebo

Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.

Locations(1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

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NCT06420375

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