A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
NCT ID: NCT05291689
Last Updated: 2025-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2022-05-24
2025-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MORF-057
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Interventions
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MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
INDUSTRY
Responsible Party
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Locations
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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
Sopot, , Poland
Clinical Study Site
Sosnowiec, , Poland
Clinical Study Site
Staszów, , Poland
Clinical Study Site
Tychy, , Poland
Clinical Study Site
Warsaw, , Poland
Clinical Study Site
Warsaw, , Poland
Countries
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References
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Sands BE, Schreiber S, Danese S, Kierkus J, Abhyankar B, Choi MY, Soo C, Wu Y, Sun F, Lee D, Cui D, Mangada M, Singhal P, Hussain A, Rogers BN, Peyrin-Biroulet L, Feagan BG. A Phase 2 Study of MORF-057, an Oral alpha4beta7 Integrin Inhibitor in Moderately to Severely Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2025 Aug 6:S1542-3565(25)00648-2. doi: 10.1016/j.cgh.2025.07.030. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J6E-MC-KWAL
Identifier Type: OTHER
Identifier Source: secondary_id
MORF-057-201
Identifier Type: OTHER
Identifier Source: secondary_id
27506
Identifier Type: -
Identifier Source: org_study_id
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