BRS201 as a new oral treatment for mild ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.