Tests BRS201 in adults with mild ulcerative colitis

Trial details

Who runs it

Brigham and Women's Hospital

Trial code

NCT06420375

Record updated

21 July 2026

Original description

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.Read full original descriptionShow less

Treatment of Ulcerative Colitis With Novel Therapeutics

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.

Inclusion: 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: Infectious Colitis or drug induced colitis; Use of rectal therapies; History of uncontrolled hypertension with systolic BP > 140 and systolic BP > 90; Crohn's Disease or Indeterminate colitis; Decompensated liver disease; Patients who have a confirmed malignancy or cancer within 5 years; Other comorbidities including: Diabetes mellitus, systemic lupus; 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.); Chronic kidney disease as defined by GFR <55mL/min; Impaired hepatic function (transaminases elevated > 2.5 x ULN) unless due to PSC; Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease; Evidence of C. difficile (Negative test result within 1 month is acceptable); Patients who are pregnant or breastfeeding; Congenital or acquired immunodeficiencies; 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.

ClinicalTrials.gov NCT06420375