Status:
COMPLETED
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
Lead Sponsor:
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Conditions:
Inflammatory Bowel Diseases
Colitis, Ulcerative
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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...
Detailed Description
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 Perio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05291689
Start Date
May 24 2022
End Date
February 19 2025
Last Update
August 14 2025
Active Locations (17)
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1
Clinical Study Site
Tampa, Florida, United States, 33609
2
Clinical Study Site
Lafayette, Louisiana, United States, 70503
3
Clinical Study Site
Freehold, New Jersey, United States, 07728
4
Clinical Study Site
Brooklyn, New York, United States, 11235