A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderate to Severe Ulcerative Colitis (UC)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphic Therapeutic, Inc

Criteria

Inclusion Criteria:

• Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening

• Has evidence of UC extending at least 15 cm from the anal verge

• Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs

• Agrees to abide by the study guidelines and requirements

• Capable of giving signed informed consent

Exclusion Criteria:

• Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease

• Has positive findings on a subjective neurological screening questionnaire

• Has a concurrent, clinically significant, serious, unstable comorbidity

• Primary non-responder to vedolizumab or other integrin inhibitors

• Participation in any other interventional study or received any investigational therapy within 30 days

• Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057

• Unable to attend study visits or comply with study procedures