Ulcerative Colitis · Ulcerative Colitis Mild
Phase 2 Study of BRS201 for Active Mild Ulcerative Colitis
This study is investigating BRS201 in adults with active mild ulcerative colitis by having each participant receive oral BRS201 and placebo for four weeks each in a randomized order.
Registry title: Treatment of UC With Novel Therapeutics
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- BRS201 or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Joshua Korzenik, MD617 732-6389jkorzenik@bwh.harvard.edu
- Sponsor
- Brigham and Women's Hospital
Research question
Does four weeks of BRS201 reduce hydrogen sulfide metabolites in plasma from baseline in people with active mild ulcerative colitis, and how do symptoms and other biomarkers change?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75.
- The study is looking for people with a confirmed ulcerative colitis diagnosis for more than three months.
- The study is looking for people with at least 15 centimeters of colon involvement confirmed by colonoscopy and fecal calprotectin above 200.
- The registry describes the intended population as having active mild ulcerative colitis and generally receiving mesalamine-based treatment.
Participation overview
What participation may involve
Participation lasts 12 weeks and includes seven study-site visits. Participants take oral study medication, keep a medication log, and provide blood, stool, and urine samples. What participation may involve: - Receive BRS201 for four weeks and placebo for four weeks in a randomized order. - Take oral study medication and record it in a medication log. - Attend seven visits, all conducted at a study site. - Have blood drawn and provide stool and urine samples for laboratory testing during the study. - Participation may include a one-time intravenous dose of study medication. The registry reports a total participation period of 12 weeks, including two four-week treatment periods. Seven visits are required, and the registry says all are conducted at the study site.
Study interventions
What participants may receive or do
- BRS201: BRS201 is the study drug. Participants receive it during one four-week period, generally as an oral medication; the registry also says some participation may involve a one-time intravenous dose.
- Placebo: The placebo is used during a separate four-week period for comparison with BRS201. Every participant is described as receiving both treatments, with their order randomized.
Study design
How the comparison works
This is a randomized Phase 2 crossover treatment study. Each participant receives BRS201 for four weeks and placebo for four weeks, but the order differs between participants. Within each five-person group, the registry says three participants start with active treatment and two start with placebo before crossing over to the other treatment. The structured design fields list participants, care providers, investigators, and outcome assessors as masked, but the accompanying description calls the study double-blinded; these statements are not fully consistent. Each participant serves as a comparison across two periods: one using BRS201 and one using placebo. The registry states that every participant receives placebo for four weeks, either before or after four weeks of active treatment.
Reported activities
Procedures and tests
- Blood draws are used to measure plasma hydrogen sulfide metabolites and other compounds including nitrite, nitrate, or nitrosothiol.
- Stool samples are used for fecal calprotectin measurements.
- Urine samples are analyzed for sulfur-related substances, including thiosulfate, thiocyanate, nitrate, and nitrite.
- Participants track study medication in a log.
- Symptoms are assessed with the Simple Clinical Colitis Activity Index, a patient-reported scale from 0 to 19.
- Disease activity is also assessed with the partial Mayo score, a scale from 0 to 9.
- Screening may require records showing at least 15 centimeters of colon involvement previously confirmed by colonoscopy.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be able to provide consent.
- A confirmed ulcerative colitis diagnosis must have been present for more than three months.
- At least 15 centimeters of colon involvement must have been confirmed by colonoscopy.
- Fecal calprotectin must be above 200.
- The registry lists mesalamine and sulfasalazine as allowed medications.
- People with primary sclerosing cholangitis may enroll if they meet the other criteria.
Possible reasons someone may not be able to join
- Chronic kidney disease with a glomerular filtration rate below 55 mL/min is excluded.
- Liver transaminases above 2.5 times the upper limit of normal are excluded unless attributed to primary sclerosing cholangitis.
- Evidence of Clostridioides difficile infection is excluded; the registry says a negative test within one month is acceptable.
- Infectious or drug-induced colitis, Crohn's disease, and indeterminate colitis are excluded.
- People who are pregnant or breastfeeding are excluded.
- Use of rectal therapies is excluded.
- A confirmed malignancy or cancer within the past five years is excluded.
- A high likelihood of needing colectomy within the next two months is excluded.
- Participation in another therapeutic clinical trial within the preceding 30 days or at the same time as this study is excluded.
- The registry excludes people with a history or risk of listed cardiovascular conditions, including arrhythmia, long QT syndrome, heart failure, stroke, or coronary artery disease.
- Vitamin C, prednisone, listed immune modulators, and several biologic or advanced therapies are prohibited; many listed therapies have a six-week restriction.
Important unknowns
What the record does not make clear
- The registry reports seven on-site visits but does not give their timing or describe what happens at each visit.
- Mesalamine and sulfasalazine are listed as allowed, and the arm descriptions mention oral butyrate, but the record does not clearly explain which background medicines continue unchanged.
- A six-week restriction is stated for many advanced therapies, but timing is not clearly specified for every prohibited medication or for rectal therapies.
- The record does not describe what treatment is available if ulcerative colitis worsens during participation.
- Prior colonoscopy confirmation of disease extent is required, but the record does not say whether a new colonoscopy or sigmoidoscopy is required.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants are compensated.
- The record does not report reimbursement or assistance for travel to the seven on-site visits.
- The record does not describe access to BRS201 after study participation ends.
- The masking fields call the study quadruple-masked while the masking description calls it double-blinded.
- The arm descriptions contain unclear or inconsistent dose wording and do not clearly identify which participants receive the possible one-time intravenous dose.
- The hypertension exclusion repeats systolic blood pressure for both thresholds, so the intended second measurement is unclear.
Before contacting the site
Questions for the study team
- What is the exact schedule and expected length of each of the seven on-site visits?
- Which oral dose, dosing frequency, and possible intravenous dose would apply to each study group?
- Which current ulcerative colitis medicines must continue, stop, or remain unchanged during the study?
- What happens if symptoms worsen, and which rescue treatments are allowed?
- Will prior colonoscopy records satisfy screening, or is a new endoscopy required?
- Which study costs are covered, and are compensation or travel reimbursements available?
- Who is blinded to treatment order, given the registry's double-blind and quadruple-masking descriptions?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis, and what are the risks of changing or pausing my current treatment for this study?
- Are there approved treatment alternatives that I should compare with this study before contacting the research team?
- Could my recent biologic, immune-modulator, JAK inhibitor, steroid, vitamin C, or rectal therapy use conflict with the study's medication rules?
- What flare-management plan would be medically appropriate if my symptoms worsen during a placebo or active-treatment period?
- How should you and the research team coordinate laboratory results, medication decisions, and urgent care during the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Brigham and Women's Hospital
- Organization class
- Other
- Organization study ID
- 2025P000585
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Crossover
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Active Comparator
Active Comparator: BRS201 Arm
In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO (2.4g with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
Interventions: Drug: BRS201
Placebo Comparator
Placebo Comparator: Placebo Arm
In Group 1 of the study, subjects will take oral placebo at 1.2g daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
Interventions: Drug: Placebo
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.
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (6)
- Ability to give consentRegistry-derived · unreviewed
- Patients with a confirmed diagnosis of UC for \> 3 monthsRegistry-derived · unreviewed
- History of ≥ 15 cm of colonic involvement as confirmed by colonoscopyRegistry-derived · unreviewed
- Disease activity based on calprotectin \> 200Registry-derived · unreviewed
- Allowed medications: mesalamine and sulfasalazineRegistry-derived · unreviewed
- Patients with primary sclerosing cholangitis are eligible to enrollRegistry-derived · unreviewed
Exclusion criteria (16)
- History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90Registry-derived · unreviewed
- Chronic kidney disease as defined by GFR \<55mL/minRegistry-derived · unreviewed
- Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSCRegistry-derived · unreviewed
- Evidence of C. difficile (Negative test result within 1 month is acceptable)Registry-derived · unreviewed
- Infectious Colitis or drug induced colitisRegistry-derived · unreviewed
- Crohn's Disease or Indeterminate colitisRegistry-derived · unreviewed
- Decompensated liver diseaseRegistry-derived · unreviewed
- Patients who are pregnant or breastfeedingRegistry-derived · unreviewed
- Use of rectal therapiesRegistry-derived · unreviewed
- Patients who have a confirmed malignancy or cancer within 5 yearsRegistry-derived · unreviewed
- Congenital or acquired immunodeficienciesRegistry-derived · unreviewed
- Other comorbidities including: Diabetes mellitus, systemic lupusRegistry-derived · unreviewed
- High likelihood of colectomy in the next 2 monthsRegistry-derived · unreviewed
- Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trialRegistry-derived · unreviewed
- Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery diseaseRegistry-derived · unreviewed
- 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.)Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Reduction of H2S metabolites in plasma
Time frame: 4 weeks
The primary endpoint for this study is the capacity of study drug to reduce metabolites of H2S in plasma from baseline (week 0) compared to the end of active treatment (4 weeks)
Secondary outcome
Simple Clinical Colitis Activity Index (SCCAI)
Time frame: 12 weeks
Clinical symptoms assessed by SCCAI which measures patient reported outcomes on a scale of 0 to 19, where a higher score indicates more severe activity and active disease is a score of 5 or more.
Secondary outcome
Plasma nitrite, nitrate, or nitrosothiol
Time frame: 8 weeks
Correlation between changes in plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin
Secondary outcome
Normalization of fecal calprotectin lab measurements
Time frame: 4 weeks
The primary endpoint for this study is the capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks).
Secondary outcome
Change in fecal calprotectin lab measurements
Time frame: 4 weeks
Change in fecal calprotectin to \< ULN at the end of active treatment
Secondary outcome
Partial Mayo score
Time frame: 4 weeks
Change in partial Mayo scores from baseline to end of active treatment. The partial Mayo score measures disease activity on a scale of 0 to 9, where a higher score indicates more severe disease activity and a score of 1 or less indicated remission.
Secondary outcome
Measurement of sulfur metabolites in urine
Time frame: 8 weeks
Analysis of urine for measurement of thiosulfate, thiocyanate, nitrate and nitrite
Recruiting locations in the United States
Brigham and Women's Hospital
RecruitingChestnut Hill, Massachusetts, 02467, United States
Siani Ellis617-396-7703sellis13@bwh.harvard.edu
Sophie Mitchellsmitchell22@bwh.harvard.edu
Joshua Korzenik, MD
Central study contacts
Registry dates
- First posted
- May 20, 2024
- Primary completion
- Dec 1, 2026
- Overall completion
- Jul 31, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.