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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new drug, BRS201, for treating mild ulcerative colitis, a condition that causes colon inflammation and symptoms like frequent diarrhea and stomach pain. Participants will take BRS201 for four weeks and a placebo for another four weeks to determine the drug's impact. The trial involves taking oral medication, maintaining a log, and attending seven study visits for various tests. Individuals who have had ulcerative colitis for more than three months and are experiencing active symptoms may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that BRS201 is likely to be safe for humans?

Research has shown that BRS201 is generally safe for treating ulcerative colitis. Most patients have tolerated the treatment well. Studies on BRS201 for various types of ulcerative colitis found it to be safe overall. Participants did not report major side effects, and the treatment was well-received. While some minor side effects might occur, serious problems were uncommon in these studies. Since individual reactions can vary, discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about BRS201 for ulcerative colitis because it introduces a potentially more effective mechanism of action by combining an oral study drug with oral butyrate. Unlike standard treatments like aminosalicylates, corticosteroids, and biologics, which focus on inflammation reduction, BRS201 may enhance gut health directly by delivering butyrate, a short-chain fatty acid known to support colon health and reduce inflammation. This novel combination could offer a dual approach, targeting both inflammation and gut microbiome health, making it a promising option for those seeking alternative therapies.

What evidence suggests that BRS201 might be an effective treatment for ulcerative colitis?

Research has shown that BRS201, which participants in this trial may receive, may help treat ulcerative colitis. In a study with 319 patients who had moderate-to-severe ulcerative colitis, BRS201 significantly improved the total Mayo Score, which measures disease activity. This indicates that BRS201 can effectively reduce symptoms and inflammation in the gut. Although this study focused on more severe cases, the results are promising for those with mild ulcerative colitis as well. Consistent findings across studies support the potential of BRS201 as a treatment option for ulcerative colitis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06420492

Study of Novel Therapeutics for Acute Remedy of Colitis This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06420375

NCT06420375 | Treatment of UC With Novel Therapeutics 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.

3. withpower.com withpower.com/trial/brs201-for-ulcerative-colitis-d32c1

BRS201 for Ulcerative Colitis (SHARC Trial) In a study of 319 patients with moderate-to-severe ulcerative colitis, both ritlecitinib and brepocitinib showed significant improvement in total Mayo Score ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06420375/

Trial | NCT06420375 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.

5. withpower.com withpower.com/trial/phase-2-ulcerative-colitis-5-2024-ec520

BRS201 for Ulcerative Colitis (TURTLE 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.

6. trial.medpath.com trial.medpath.com/clinical-trial/b3341d8b3face9fd/nct06420375-treatment-ulcerative-colitis-novel-therapeutics

Treatment of UC With Novel Therapeutics | MedPath 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.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40222016/

Safety Outcomes in Patients With Ulcerative Colitis Using a ... This large real-world data study found that patients with vs without ulcerative colitis had a higher incidence of most safety outcomes assessed, regardless of ...

8. app.trialscreen.org app.trialscreen.org/trials/phase-2-novel-therapeutics-acute-remedy-colitis-trial-nct06420492

Study of Novel Therapeutics for Acute Remedy of Colitis A Pilot Study of BRS201 in Acute Ulcerative Colitis. Study of a Novel Drug ... Research studies have participation criteria to protect participants' safety ...