A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC (NCT05291689) | Clinical Trial Compass
CompletedPhase 2
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
United States39 participantsStarted 2022-04-13
Plain-language 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 Moderately to Severely Active Ulcerative Colitis (UC)
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-naĂ¯ve 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
What they're measuring
1
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Timeframe: From baseline to 12 weeks
Trial details
NCT IDNCT05291689
SponsorMorphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)