Treatment of UC With Novel Therapeutics

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis Mild, Ulcerative Colitis

In brief

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. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 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.

Key facts

Study ID: NCT06420375
Run by: Brigham and Women's Hospital
People needed: 20
Starts: 2025-05-27
Expected to finish: 2027-07-31
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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