BRS201 as a new oral treatment for mild ulcerative colitis
Treatment of Ulcerative Colitis With Novel Therapeutics
This 12-week test checks whether taking the oral medication BRS201 can reduce inflammation and symptoms in adults with active mild ulcerative colitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | mirikizumab, vedolizumab, ustekinumab, Risankizumab, tofacitinib, upadacitinib, prednisone |
| Locations | 1 site (Chestnut Hill, Massachusetts) |
| Trial ID | NCT06420375 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized crossover study enrolls adults with active mild ulcerative colitis and >15 cm of colonic involvement. Participants will receive BRS201 for 4 weeks and placebo for 4 weeks in randomized order (oral medication taken twice daily), and some participants may also receive an IV dose. The protocol requires seven in-person visits at the study site and periodic blood, stool, and urine tests, with medication adherence tracked in a dosing log. Background use of mesalamine or sulfasalazine is permitted, and eligibility is driven by fecal calprotectin >200 and other inclusion/exclusion criteria.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of ulcerative colitis for over 3 months, active mild disease (fecal calprotectin >200), at least 15 cm of colonic involvement, able to attend site visits, and stable on allowed medications such as mesalamine or sulfasalazine are ideal candidates.
Not a fit: Patients with Crohn's disease, indeterminate colitis, decompensated liver disease, significant kidney impairment (GFR <55), recent cancer, pregnancy or breastfeeding, use of rectal therapies, or active infectious colitis are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, BRS201 could offer a new oral option to reduce intestinal inflammation and improve symptoms in people with mild ulcerative colitis.
How similar studies have performed: Oral anti-inflammatory agents and small-molecule drugs have shown benefit in ulcerative colitis, but BRS201 itself appears to be a novel agent and has not been proven effective prior to this Phase 2 trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Chestnut Hill, Massachusetts
- Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Joshua Korzenik, MD
- Email: jkorzenik@bwh.harvard.edu
- Phone: 617 732-6389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.