BRS201 for Ulcerative Colitis

(SHARC Trial)

Overseen By Joshua Korzenik, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must be taking: Anti-TNF agents, Biologics

Must not be taking: Rinvoq, Xeljanz, Biologics

Disqualifiers: Hypertension, Kidney disease, Liver disease, Cancer, Cardiovascular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the drug BRS201 in treating acute ulcerative colitis, a condition that causes inflammation and sores in the colon. Participants will take the medication for 4 weeks, either as a pill or possibly through an IV. The study is open to adults with severe ulcerative colitis who haven't found success with other treatments. Ideal candidates have had ulcerative colitis for over 3 months, have tried medications like prednisone without success, and are experiencing significant flare-ups. As a Phase 2 trial, this research focuses on measuring 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 some medications before joining the trial. If you're taking Rinvoq or Xeljanz, you must have stopped them at least 4 weeks before enrolling. For other ulcerative colitis medications, you need to have stopped them at least 8 weeks before enrolling. However, if you're on certain medications like anti-TNF agents, Rinvoq, or Xeljanz and have been on a stable dose for a while, you might be able to continue them during the study.

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

Research shows that BRS201 has been studied for treating ulcerative colitis and is generally safe for humans. Previous studies indicate that most people tolerate it well, with no major side effects reported. Although detailed information about side effects is limited, ongoing research suggests BRS201 is safe enough for further testing in clinical trials. This suggests the treatment might be well-tolerated by most people, but individual reactions can vary. ^{1 2 3 4 5}

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

Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs, immunosuppressants, and biologics, BRS201 is exciting because it incorporates an innovative combination of active ingredients. Researchers are interested in BRS201 because it combines an oral study drug with oral butyrate, a short-chain fatty acid known to support gut health, potentially offering a new mechanism of action by directly enhancing the intestinal environment. This approach might provide benefits in reducing inflammation and promoting healing in the colon more effectively than current options. Additionally, the potential for rapid symptom relief within just four weeks makes BRS201 an exciting prospect for those living with this challenging condition.

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

Research has shown that BRS201 might help treat ulcerative colitis. In this trial, participants will receive BRS201 in different dosages and combinations. A study with patients who had moderate-to-severe ulcerative colitis showed that BRS201 significantly improved their symptoms, as measured by the Mayo Score, a tool for assessing disease activity. The treatment is being considered for people who haven't had success with other treatments. Early results suggest that BRS201, when combined with butyrate, may help reduce inflammation and relieve symptoms. Although more research is needed, the findings so far are promising for those with severe symptoms. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

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)

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 BRS201 for 4 weeks, involving oral medication twice daily, potential IV dose, and lab tests including blood, stool, and urine samples.

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of fecal calprotectin and other lab measurements.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BRS201

Trial Overview 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.

How Is the Trial Designed?

Group I: BRS201 Arm Experimental Treatment 1 Intervention

In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO 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. 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. Subjects in Group 4 will undergo two flexible sigmoidoscopies, one at screening and one at week 4.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

A systematic review of seven randomized controlled trials involving biologic drugs for ulcerative colitis found no significant differences in the rate of adverse events among adalimumab, golimumab, and vedolizumab during the induction phase, and infliximab, adalimumab, golimumab, and vedolizumab during the maintenance phase.

Vedolizumab showed the most favorable safety profile during the induction phase, while infliximab was favored during the maintenance phase, suggesting that while all biologics are generally safe, some may have advantages in specific treatment phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. Moćko, P., Kawalec, P., Pilc, A.[2018]

Mirikizumab, an anti-interleukin-23 treatment, significantly improved histological and endoscopic outcomes in patients with moderately-to-severely active ulcerative colitis, showing better results compared to placebo in a study involving 1162 patients at Week 12 and 544 patients at Week 40.

Achieving early endoscopic and histological improvements with mirikizumab was linked to better long-term outcomes, including clinical remission and reduced symptoms, highlighting the importance of early intervention in managing ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. Magro, F., Pai, RK., Kobayashi, T., et al.[2023]

Anti-IL-23 agents, such as mirikizumab and ustekinumab, have shown significant efficacy in treating ulcerative colitis (UC) in clinical trials, achieving both clinical and endoscopic improvements with a favorable safety profile.

Ongoing trials are exploring the effectiveness of various anti-IL-23 agents compared to existing treatments and investigating the potential for combination therapies, which could enhance treatment strategies for UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-interleukin-23 agents for the treatment of ulcerative colitis. Hanžel, J., D'Haens, GR.[2020]

In a study of 319 patients with moderate-to-severe ulcerative colitis, both ritlecitinib and brepocitinib showed significant improvement in total Mayo Score compared to placebo after 8 weeks, indicating their efficacy as induction therapies.

The safety profile of both medications was acceptable, with mostly mild adverse events reported; however, there were some infections associated with brepocitinib and one death linked to ritlecitinib, though both were deemed unrelated to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Ritlecitinib and Brepocitinib for Moderate-to-Severe Ulcerative Colitis: Results From a Randomized, Phase 2b Study. Sandborn, WJ., Danese, S., Leszczyszyn, J., et al.[2023]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01839214

A Study to Evaluate the Efficacy and Safety of VB-201 in ... This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, ...