BRS201 for Ulcerative Colitis
(SHARC Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 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. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.

Eligibility Criteria

Adults with severe ulcerative colitis that hasn't improved with other treatments can join this study. It involves taking an oral medication twice daily, attending 7 visits for tests like blood draws and stool samples, and possibly receiving an IV dose.

Inclusion Criteria

I have primary sclerosing cholangitis.

I've taken high-dose steroids for a few days without improvement in my condition.

I have been diagnosed with ulcerative colitis for more than 3 months.

+5 more

Exclusion Criteria

I have colitis caused by an infection or medication.

My blood pressure is not controlled and is often above 140/90.

Evidence of C. difficile (Negative test result within 1 month is acceptable)

+12 more

Participant Groups

The trial is testing BRS201's effectiveness for acute ulcerative colitis over a period of 12 weeks. This open-label pilot study requires participants to take the drug orally for 4 weeks and track their usage.

1Treatment groups

Experimental Treatment

Group I: BRS201 ArmExperimental Treatment1 Intervention

In Group 1 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 2g twice daily, PO (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 2g twice daily, PO (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.