A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
Completed · Phase 2
Conditions studied: Inflammatory Bowel Diseases, Colitis, Ulcerative
In brief
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)
Key facts
- Study ID
- NCT05291689
- Run by
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
- People needed
- 39
- Starts
- 2022-04-13
- Expected to finish
- 2025-02-19
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Study Site — Sosnowiec, Poland
- Clinical Study Site — Tampa, Florida, United States
- Clinical Study Site — Lafayette, Louisiana, United States
- Clinical Study Site — Freehold, New Jersey, United States
- Clinical Study Site — Brooklyn, New York, United States
- Clinical Study Site — New York, New York, United States
- Clinical Study Site — Bydgoszcz, Poland
- Clinical Study Site — Elblag, Poland
- Clinical Study Site — Katowice, Poland
- Clinical Study Site — Lodz, Poland
- Clinical Study Site — Lodz, Poland
- Clinical Study Site — Oświęcim, Poland
- Clinical Study Site — Staszów, Poland
- Clinical Study Site — Tychy, Poland
- Clinical Study Site — Warsaw, Poland
- Clinical Study Site — Warsaw, Poland
- Clinical Study Site — Sopot, Poland
Full record on ClinicalTrials.gov
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