Actively Recruiting
Treatment of UC With Novel Therapeutics
Led by Brigham and Women's Hospital · Updated on 2025-06-11
20
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of UC With Novel Therapeutics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to give consent
- Confirmed diagnosis of ulcerative colitis for more than 3 months
- History of at least 15 cm of colon involvement confirmed by colonoscopy
- Disease activity with calprotectin greater than 200
- Allowed medications include mesalamine and sulfasalazine
- Patients with primary sclerosing cholangitis are eligible
You will not qualify if you...
- History of uncontrolled hypertension with systolic blood pressure over 140 and diastolic blood pressure over 90
- Chronic kidney disease with glomerular filtration rate less than 55 mL/min
- Impaired liver function with transaminases more than 2.5 times the upper limit of normal unless due to primary sclerosing cholangitis
- Evidence of Clostridium difficile infection (negative test within 1 month acceptable)
- Infectious colitis or drug-induced colitis
- Diagnosis of Crohn's disease or indeterminate colitis
- Decompensated liver disease
- Pregnant or breastfeeding
- Use of rectal therapies
- History or current malignancy within 5 years
- Congenital or acquired immunodeficiencies
- Other comorbidities including diabetes mellitus and systemic lupus
- High likelihood of colectomy within the next 2 months
- Participation in another therapeutic clinical trial within the last 30 days or concurrently
- History or risk of cardiovascular conditions such as arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
- Use of prohibited medications including vitamin C, prednisone, immune modulators, and biologics within the past 6 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
Research Team
J
Joshua Korzenik, MD
CONTACT
S
Siani Ellis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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