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