Treatment of UC With Novel Therapeutics

NCT06420375 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025P000585
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduction of H2S metabolites in plasma

  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)

  4 weeks

Secondary Outcomes (6)

• Simple Clinical Colitis Activity Index (SCCAI)

  12 weeks

• Plasma nitrite, nitrate, or nitrosothiol

  8 weeks

• Normalization of fecal calprotectin lab measurements

  4 weeks

• Change in fecal calprotectin lab measurements

  4 weeks

• Partial Mayo score

  4 weeks

Study Arms (2)

Active Comparator: BRS201 Arm

ACTIVE COMPARATOR

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.

Drug: BRS201

Placebo Comparator: Placebo Arm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

BRS201 DRUG

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.

Active Comparator: BRS201 Arm

Placebo DRUG

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 Comparator: Placebo Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Joshua Korzenik, MD

CONTACT

617 732-6389; jkorzenik@bwh.harvard.edu

Siani Ellis

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-Director, Brigham and Women's Hospital Crohn's and Colitis Center

Model Details: This is a crossover study in which each participant will receive active medication for a period of time and placebo for a period of time.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 20, 2024
• Study Start: May 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)