Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05611671

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

Conditions: Inflammatory Bowel Diseases, Colitis, Ulcerative

Sex: All
Ages: 18 Years – 85 Years
Phase: PHASE2
Enrollment: 280
Sponsor: Morphic Therapeutic, Inc

Location: United States

Summary

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Eligibility Criteria

Inclusion Criteria:Has signs/symptoms of moderate to severe UC for at least 3 months prior to ScreeningHas evidence of UC extending at least 15 cm from the anal vergeDemonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists)Subject has no prior exposure to approved or investigational anti-integrin therapiesAgrees to abide by the study guidelines and requirementsCapable of giving signed informed consentExclusion Criteria:Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's diseaseHas positive findings on a subjective neurological screening questionnaireHas a concurrent, clinically significant, serious, unstable comorbidityPrevious treatment with vedolizumab or other licensed or investigational integrin inhibitorsParticipation in any other interventional study or received any investigational therapy within 30 daysPrevious exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057Unable to attend study visits or comply with study procedures

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611671). StuddyBuddy aggregates publicly available trial information.