Recruiting

Phase 2

BRS201Treatment of UC With Novel Therapeutics

Sponsor:

Brigham and Women's Hospital

Code:

NCT06420375

Conditions

Ulcerative Colitis Mild

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BRS201

Placebo

Study Details

Brief summary:

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

Ulcerative Colitis Mild

Ulcerative Colitis

Study ID

NCT06420375

Start date

May 27, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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

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.

Placebo

Primary outcome measure

Reduction of H2S metabolites in plasma [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Joshua Korzenik, MD

617 732-6389 jkorzenik@bwh.harvard.edu

Siani Ellis

617-396-7703 sellis13@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Contacts

Siani Ellis

617-396-7703 sellis13@bwh.harvard.edu

Sophie Mitchell

smitchell22@bwh.harvard.edu

Principal Investigator:

Joshua Korzenik, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-21.