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Anti-inflammatory

BRS201 for Ulcerative Colitis (SHARC Trial)

Phase 2

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients will have failed 3 days of IV steroids or 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of > 6

Severe outpatient or hospitalized for an acute UC flare

Must not have

Patients are planned to be started on a fast- acting medication including an anti-TNF agent (infliximab, adalimumab, golimumab, certolizumab), on a JAKi (upadacitinib, tofacitinib)

Infectious Colitis or drug induced colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the drug BRS201 as a treatment for severe ulcerative colitis in adults who have not responded to other treatments. Participants will take the study drug orally for 4 weeks and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified in the provided information. However, as with any medication, there may be risks of adverse reactions which will be monitored through lab tests and study visits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been hospitalized or treated as an outpatient for a severe ulcerative colitis flare-up.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am starting a fast-acting medication like an anti-TNF or JAK inhibitor.

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I have colitis caused by an infection or medication.

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I was diagnosed with cancer within the last 5 years.

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I have diabetes or lupus.

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My liver is not working properly.

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I have a weakened immune system from birth or due to a condition.

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

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

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I have Crohn's Disease or my condition is possibly Crohn's.

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I have a history or risk of heart conditions like arrhythmia or heart failure.

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I haven't taken Vitamin C, prednisone, immune modulators, or anti-TNF agents in the last six weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mayo Score

Secondary study objectives

Normalization of fecal calprotectin lab measurements

Plasma nitrite, nitrate, or nitrosothiol

Reduction in fecal calprotectin lab measurements

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 14Eligibility criteria met