Treatment of Ulcerative Colitis With Novel Therapeutics

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 2

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: f

View:

• 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

Locations

United States

Massachusetts

Brigham and Women's Hospital

RECRUITING

Chestnut Hill

Contact Information

Primary

Joshua Korzenik, MD

jkorzenik@bwh.harvard.edu

617 732-6389

Backup

Siani Ellis

sellis13@bwh.harvard.edu

617-396-7703

Time Frame

Start Date: 2025-05-27

Estimated Completion Date: 2027-07-31

Participants

Target number of participants: 20

Treatments

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.

Related Therapeutic Areas

Ulcerative Colitis

Hemorrhagic Proctocolitis

Viral Gastroenteritis

Colitis

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Treatment of Ulcerative Colitis With Novel Therapeutics

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