UCRecruiting
Treatment of UC With Novel Therapeutics
Phase 2 · Testing BRS201 · 1 site · Brigham and Women's Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing BRS201 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis Mild and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2025-05-27.
- Main results expected around 2026-12-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Reduction of H2S metabolites in plasma (4 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis Mild; Ulcerative Colitis |
| Lead sponsor | Brigham and Women's Hospital |
| Collaborators | Mercy Medical Center; Dartmouth-Hitchcock Medical Center |
| Enrollment | 20 (estimated) |
| Start date | 2025-05-27 |
| Primary completion (est.) | 2026-12-01 |
| First posted | 2024-05-20 |
| Last updated | 2026-07-21 |
| Official title | Treatment of Ulcerative Colitis With Novel Therapeutics |
| ClinicalTrials.gov ID | NCT06420375 |
Interventions
- BRS201 (Drug)
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. - Placebo (Drug)
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.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 * Disease activity based on calprotectin > 200 * Allowed medications: mesalamine and sulfasalazine * Patients with primary sclerosing cholangitis are eligible to enroll Exclusion Criteria: * 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 * Use of rectal therapies * Patients who have a confirmed malignancy or cancer within 5 years * Congenital or acquired immunodeficiencies * Other comorbidities including: Diabetes mellitus, systemic lupus * High likelihood of colectomy in the next 2 months * 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: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10, interleukin-11, and Omvoh or mirikizumab-mrkz) and biologics within the past six weeks including anti-TNF agents within the past six weeks, vedolizumab within the past six weeks, ustekinumab Risankizumab), a JAKi (tofacitinib or upadacitinib), or Velsipity (etrasimod) within the past 6 weeks. (The aim is to treat people who are having disease activity and just on mesalamine.)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital | Chestnut Hill, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.