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

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)

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

The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

Inclusion Criteria:

• Has signs/symptoms of moderately to severely active 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