Actively Recruiting
Study of Novel Therapeutics for Acute Remedy of Colitis
Led by Brigham and Women's Hospital · Updated on 2025-10-20
20
Participants Needed
2
Research Sites
87 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 acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks 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 8 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. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.
CONDITIONS
Official Title
Study of Novel Therapeutics for Acute Remedy of Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Severe outpatient or hospitalized for an acute ulcerative colitis flare
- Ability to give consent
- Confirmed diagnosis of ulcerative colitis for more than 3 months
- History of 15 cm or more of colonic involvement confirmed by colonoscopy
- Patients with primary sclerosing cholangitis are eligible
- Failed 5 days of oral prednisone 30 mg or greater with SCCAI over 6
- Taking 20 mg or less of oral prednisone and plan to maintain this dose during the study
- Use of anti-TNF agents for at least 10 weeks with planned stable dose
- Use of Rinvoq (Upadacitinib) for at least 4 weeks with planned stable dose
- Use of Xeljanz (Tofacitinib) for at least 4 weeks with planned stable dose
- Use of other biologics for at least 10 weeks with planned stable dose
You will not qualify if you...
- History of uncontrolled hypertension with systolic BP over 140 and diastolic BP over 90
- Chronic kidney disease with GFR less than 55 mL/min
- Impaired liver function with transaminases over 2.5 times the upper limit of normal unless caused by primary sclerosing cholangitis
- Positive test for C. difficile infection within 1 month
- Infectious or drug-induced colitis
- Diagnosis of Crohn's disease or indeterminate colitis
- Decompensated liver disease
- Pregnant or breastfeeding
- Confirmed malignancy or cancer within the past 5 years
- Congenital or acquired immunodeficiencies
- Other comorbidities including diabetes mellitus and systemic lupus
- Participation in another therapeutic clinical trial within the past 30 days or concurrent with this study
- History or risk of cardiovascular conditions such as arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
- Use of Rinvoq (Upadacitinib) within 4 weeks prior to enrollment
- Use of Xeljanz (Tofacitinib) within 4 weeks prior to enrollment
- Use of other ulcerative colitis medications stopped within 8 weeks prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Not Yet Recruiting
2
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
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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