Ulcerative Colitis · Ulcerative Colitis Chronic Moderate · Ulcerative Colitis Chronic Severe
BRS201 for Adults With Acute Severe Ulcerative Colitis
This open-label Phase 2 study is investigating BRS201 in adults with acute severe ulcerative colitis that has not responded adequately to treatment.
Registry title: Study of Novel Therapeutics for Acute Remedy of Colitis
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- BRS201
- Design
- Not provided
- Central study contact
- Joshua Korzenik, MD617 732-6389jkorzenik@bwh.harvard.edu
- Sponsor
- Brigham and Women's Hospital
Research question
Researchers are asking how BRS201 affects sulfur-metabolism measurements and clinical or laboratory signs of ulcerative colitis after treatment.
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 lasting more than three months.
- The study is looking for outpatients with severe disease or hospitalized patients experiencing an acute ulcerative colitis flare.
- The study is looking for people whose flare remains active after at least five days of oral prednisone at 30 mg or more.
- The study is being conducted at Brigham and Women's Hospital in Chestnut Hill, Massachusetts.
Participation overview
What participation may involve
Participation lasts 12 weeks and includes four weeks of active BRS201 treatment, medication tracking, laboratory samples, and follow-up assessments. What participation may involve: - Take oral study medication twice daily and record doses in a medication log. - Some participants may receive a one-time intravenous dose of the study medication. - Provide blood, stool, and urine samples for laboratory testing during the study. - Participants may undergo flexible sigmoidoscopy at the beginning and end of the study; the arm description specifically requires two for Group 4. The registry states that participation lasts 12 weeks, including four weeks of active study-drug treatment. The registry reports eight visits, all conducted at a study site.
Study interventions
What participants may receive or do
- BRS201: All participants receive active BRS201 for four weeks. The registry describes oral dosing with oral butyrate and states that participation may also involve a one-time intravenous dose.
Study design
How the comparison works
This is a Phase 2, open-label, single-group pilot study with an estimated enrollment of 20 participants; everyone receives active treatment. The registry reports allocation as not applicable and does not describe random assignment. The study is open-label with no masking, so participants and study staff know that active treatment is being given. No separate control or comparator group is described; the registry lists one experimental arm. No placebo is described, and the registry states that everyone receives active treatment.
Reported activities
Procedures and tests
- Blood draws for laboratory testing, including plasma nitrite, nitrate, or nitrosothiol measurements.
- Stool samples for fecal calprotectin testing.
- Urine samples for sulfur-metabolism and related assays, including sulfate, thiosulfate, thiocyanate, nitrate, and nitrite.
- Symptom assessment using the Simple Clinical Colitis Activity Index, a patient-reported scale from 0 to 19.
- Ulcerative colitis assessment using the Mayo Score.
- Flexible sigmoidoscopy may occur at the beginning and end of the study; Group 4 is described as having procedures at screening and week 4.
- Tissue analysis comparing metabolomics and proteomics at day 0 and day 28.
- Evaluation of changes in mitochondria using electron microscopy.
- A medication log used to track study-drug doses.
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 18 through 75 years old.
- Participants must be severe outpatients or hospitalized for an acute ulcerative colitis flare.
- Ulcerative colitis must have been confirmed for more than three months.
- Participants must have a history of at least 15 cm of colon involvement confirmed by colonoscopy.
- Participants must still have a Simple Clinical Colitis Activity Index above 6 after five days of oral prednisone at 30 mg or more.
- Participants taking oral prednisone must be taking 20 mg or less and plan to remain at that dose during the study.
- Ongoing anti-tumor necrosis factor therapy or another biologic is permitted after at least 10 weeks if the dose will remain steady during the study.
- Ongoing upadacitinib or tofacitinib is permitted after at least four weeks if the dose will remain steady during the study.
Possible reasons someone may not be able to join
- People with evidence of Clostridioides difficile are excluded; a negative test within one month is acceptable.
- People with infectious colitis or drug-induced colitis are excluded.
- People with Crohn's disease or indeterminate colitis are excluded.
- Chronic kidney disease with a glomerular filtration rate below 55 mL/min is exclusionary.
- Impaired liver function with transaminases above 2.5 times the upper limit of normal is exclusionary unless caused by primary sclerosing cholangitis.
- People who are pregnant or breastfeeding are excluded.
- A confirmed malignancy or cancer within the past five years is exclusionary.
- People with specified cardiovascular conditions or risks, including arrhythmia, long QT syndrome, heart failure, stroke, or coronary artery disease, are excluded.
- Participation in another therapeutic clinical trial within the preceding 30 days or at the same time is exclusionary.
- If upadacitinib or tofacitinib was stopped, the last dose must have been more than four weeks before enrollment; for other stopped ulcerative colitis medicines, the last dose must have been more than eight weeks before enrollment.
- Uncontrolled hypertension is exclusionary, but the registry repeats 'systolic' for both reported thresholds, so the exact blood-pressure rule needs confirmation.
Important unknowns
What the record does not make clear
- The registry permits several ongoing ulcerative colitis treatments at stable doses, but it does not fully explain which background treatments must continue or how treatment changes during the study would be handled.
- The record does not describe rescue-treatment options if ulcerative colitis worsens during participation.
- The summary says participants may undergo flexible sigmoidoscopy, while the arm description specifically requires screening and week-4 procedures for Group 4.
- The arm description repeats Group 3, does not describe Group 2 by name, and does not clearly explain how participants are placed into the four dosing groups.
- 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 receive compensation.
- The record does not state whether transportation, parking, lodging, or other travel support is available.
- The record does not describe access to BRS201 after the four-week treatment period or after study completion.
- Two entries for the same Brigham and Women's Hospital location list different statuses: one recruiting and one not yet recruiting.
Before contacting the site
Questions for the study team
- What are the four dosing groups, and how will you decide which BRS201 dose and route a participant receives?
- Would I need flexible sigmoidoscopy, and would tissue biopsies be collected during each procedure?
- Which current ulcerative colitis medicines must remain stable, and what happens if my treatment needs to change?
- What treatment or urgent-care plan applies if my flare worsens during the study?
- Which Chestnut Hill cohorts are currently accepting participants?
- Which costs are covered, is compensation offered, and is travel or parking support available?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what risks would four weeks of BRS201 study treatment pose in my clinical situation?
- Would any of my current ulcerative colitis medicines need to change, and would keeping them stable be medically appropriate?
- What approved treatment alternatives should I consider alongside learning more about this trial?
- How should your office and the research team coordinate monitoring, medication decisions, and a plan for worsening symptoms?
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 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.
Study design and administration
- Organization
- Brigham and Women's Hospital
- Organization class
- Other
- Organization study ID
- 2025P001885
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
BRS201 Arm
In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO 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. 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. Subjects in Group 4 will undergo two flexible sigmoidoscopies, one at screening and one at week 4.
Interventions: Drug: BRS201
Interventions
Drug
BRS201
Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (12)
- Severe outpatient or hospitalized for an acute UC flareRegistry-derived · unreviewed
- 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
- Patients with primary sclerosing cholangitis are eligible to enrollRegistry-derived · unreviewed
- Patients will have failed 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \> 6Registry-derived · unreviewed
- Patients who are taking 20mg or less of oral prednisone and plan to stay at that dose during their participation in the studyRegistry-derived · unreviewed
- Accepted medications:Registry-derived · unreviewed
- Anti-TNF agents are permissible if the patient has been taking them for at least 10 weeks and anticipates to maintain a steady for the duration of the study.Registry-derived · unreviewed
- Rinvoq (Upadacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.Registry-derived · unreviewed
- Xeljanz (Tofacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.Registry-derived · unreviewed
- Other biologics are permissible if the subject has been taking the medication for at least 10 weeks and anticipates to maintain a steady dose for the duration of the studyRegistry-derived · unreviewed
Exclusion criteria (17)
- 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
- 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
- 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:Registry-derived · unreviewed
- Rinvoq (Upadacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.Registry-derived · unreviewed
- Xeljanz (Tofacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.Registry-derived · unreviewed
- Other Medications: Subjects will be excluded from this study if they stopped taking any other medications for ulcerative colitis within 8 weeks. If subjects have stopped taking the medication and their last dose was more than 8 weeks prior to enrollment, they will be eligible for participation.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
Sulfur Metabolism
Time frame: 4 weeks
The primary measure of dose response will be urinary measures of sulfur metabolism including a \> 50% reduction from pretreatment levels sulfate, and thiosulfate.
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 level in relation to calprotectin
Secondary outcome
Normalization of fecal calprotectin lab measurements
Time frame: 8 weeks
The capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks) and at week 6.
Secondary outcome
Reduction in fecal calprotectin lab measurements
Time frame: 4 weeks
Reduction in fecal calprotectin to \< ULN at the end of active treatment
Secondary outcome
Mayo Score
Time frame: 4 weeks
The primary endpoint for this study is change in Total Mayo Score with improvement being a reduction in 3 points and remission being a score of 0 or 1 from day 0 to end of week 4 (at second flexible sigmoidoscopy).
Secondary outcome
Tissue Analysis
Time frame: 4 weeks
Analysis of tissue metabolomics and proteomics at day 0 vs day 28;
Secondary outcome
Mitochondria evaluation
Time frame: 12 weeks
Changes in mitochondria on EM evaluation
Secondary outcome
Urine Assays
Time frame: 12 weeks
Urine levels for thiosulfate, thiocyanate, nitrate and nitrite;
Recruiting locations in the United States
Brigham and Women's Hospital
Not Yet RecruitingChestnut Hill, Massachusetts, 02467, United States
Siani Ellis617-396-7703sellis13@bwh.harvard.edu
Sophie Mitchellsmitchell22@bwh.harvard.edu
Joshua Korzenik, MD
Brigham and Women's Hospital
RecruitingChestnut Hill, Massachusetts, 02467, United States
Siani Ellis617-396-7703sellis13@bwh.harvard.edu
Central study contacts
Registry dates
- First posted
- May 20, 2024
- Primary completion
- Dec 1, 2026
- Overall completion
- Jun 1, 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.