Treatment of UC With Novel Therapeutics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRS201, Placebo.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis Mild, Ulcerative Colitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Ulcerative Colitis With Novel Therapeutics
Overview
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.
Interventions
- Drug BRS201
Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks. - Drug Placebo
Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.
Primary outcome measures
- Reduction of H2S metabolites in plasma [Time frame: 4 weeks]
Secondary outcome measures (6)
- Simple Clinical Colitis Activity Index (SCCAI) [Time frame: 12 weeks]
- Plasma nitrite, nitrate, or nitrosothiol [Time frame: 8 weeks]
- Normalization of fecal calprotectin lab measurements [Time frame: 4 weeks]
- Change in fecal calprotectin lab measurements [Time frame: 4 weeks]
- Partial Mayo score [Time frame: 4 weeks]
- Measurement of sulfur metabolites in urine [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Chestnut Hill
Identifiers
NCT: NCT06420375 · 2025P000585