NCT06420375RecruitingPhase 2
Treatment of UC With Novel Therapeutics
Treatment of Ulcerative Colitis With Novel Therapeutics
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 May 2024
- Start date
- 27 May 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Ulcerative colitis
- NCT number
- NCT06420375
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 27 May 2025 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infectious Colitis or drug induced colitis
- Use of rectal therapies
Other illness
- 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.)
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Chestnut Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.