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A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Has signs/symptoms of CD for at least 90 days prior to screening * Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points * Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum) * Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products) Key Exclusion Criteria: * Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC * Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement * Has had extensive bowel resection (\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome * Is currently receiving total parenteral nutrition, tube feeding, or a formula diet * Has positive findings on a subjective neurological screening questionnaire * Has a concurrent, clinically significant, serious, unstable comorbidity * Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors * Is currently participating in any other interventional study or has 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 * Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease
About the study
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
What is being tested
- Placebo (drug)
- MORF-057 (drug)
Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) · Participants: 385 · Started: Jul 18, 2024
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT06226883
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.