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RECRUITING
NCT06420492
PHASE2

Study of Novel Therapeutics for Acute Remedy of Colitis

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-09-30

Completion Date

2027-06-01

Last Updated

2025-10-20

Healthy Volunteers

No

Interventions

DRUG

BRS201

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