UCRecruiting
Study of Novel Therapeutics for Acute Remedy of Colitis
Phase 2 · Testing BRS201 · 2 sites · 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, Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe.
It is open-label: participants know what they are receiving.
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:
- Severe outpatient or hospitalized for an acute UC flare
- Ability to give consent
- Patients with a confirmed diagnosis of UC for > 3 months
Plus 9 more requirement(s). There are also 17 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: 2025-09-30.
- Main results expected around 2026-12-01 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in United States.
Main thing being measured
- Sulfur Metabolism (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 acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis.
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; Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe |
| Lead sponsor | Brigham and Women's Hospital |
| Enrollment | 20 (estimated) |
| Start date | 2025-09-30 |
| Primary completion (est.) | 2026-12-01 |
| First posted | 2024-05-20 |
| Last updated | 2025-10-20 |
| Official title | Study of Novel Therapeutics for Acute Remedy of Colitis |
| ClinicalTrials.gov ID | NCT06420492 |
Interventions
- BRS201 (Drug)
Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.
Full eligibility criteria (from the record)
Inclusion Criteria: * Severe outpatient or hospitalized for an acute UC flare * 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 * Patients with primary sclerosing cholangitis are eligible to enroll * Patients will have failed 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of > 6 * Patients who are taking 20mg or less of oral prednisone and plan to stay at that dose during their participation in the study * Accepted medications: * Anti-TNF agents are permissible if the patient has been taking them for at least 10 weeks and anticipates to maintain a steady for the duration of the study. * Rinvoq (Upadacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study. * Xeljanz (Tofacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study. * Other biologics are permissible if the subject has been taking the medication for at least 10 weeks and anticipates to maintain a steady dose for the duration of the study 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 * Patients who have a confirmed malignancy or cancer within 5 years * Congenital or acquired immunodeficiencies * Other comorbidities including: Diabetes mellitus, systemic lupus * 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: * Rinvoq (Upadacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation. * Xeljanz (Tofacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation. * Other Medications: Subjects will be excluded from this study if they stopped taking any other medications for ulcerative colitis within 8 weeks. If subjects have stopped taking the medication and their last dose was more than 8 weeks prior to enrollment, they will be eligible for participation.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital | Chestnut Hill, Massachusetts | United States | Not yet recruiting |
| 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.