BRS201 for Ulcerative Colitis

(TURTLE Trial)

Overseen By Siani Ellis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must be taking: Mesalamine, Sulfasalazine

Must not be taking: Vitamin C, Prednisone, Biologics, others

Disqualifiers: Hypertension, Kidney disease, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

20 Participants Needed

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 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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. The trial allows mesalamine and sulfasalazine, but prohibits others like Vitamin C, prednisone, and various immune modulators and biologics. If you're on any of these prohibited medications, you might need to stop them at least six weeks before starting the trial.

Eligibility Criteria

This trial is for people with active mild ulcerative colitis. Participants will be involved in the study for 12 weeks and must attend 7 visits at the study site. They'll take an oral medication twice daily, keep a log of their medication intake, and provide blood, stool, and urine samples.

Inclusion Criteria

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

Ability to give consent

Disease activity based on calprotectin > 200

Exclusion Criteria

I have Crohn's Disease or my condition is similar but not specifically diagnosed.

My kidney function is reduced with a GFR under 60 mL/min.

Patients who are pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive the study drug and placebo in a crossover design for 8 weeks

8 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• BRS201

Trial Overview The efficacy of BRS201 is being tested against a placebo in treating ulcerative colitis. It's a crossover study where participants switch between the drug and placebo every four weeks to compare effects.

Participant Groups

Group I: Active Comparator: BRS201 Arm Active Control 1 Intervention

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.

Group II: Placebo Comparator: Placebo Arm Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+