Trials / Recruiting
RecruitingNCT06420492
Study of Novel Therapeutics for Acute Remedy of Colitis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BRS201 | Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks. |
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2026-12-01
- Completion
- 2027-06-01
- First posted
- 2024-05-20
- Last updated
- 2025-10-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06420492. Inclusion in this directory is not an endorsement.