NCT06226883

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 385 (estimated)
• Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.

Conditions

• Inflammatory Bowel Diseases
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo (identical appearance to MORF-057) administered orally.
DRUG	MORF-057	MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Timeline

• Start date: 2024-07-18
• Primary completion: 2028-09-01
• Completion: 2030-06-01
• First posted: 2024-01-26
• Last updated: 2026-04-17

Locations

215 sites across 26 countries: United States, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Hungary, India, Italy, Japan, Kazakhstan, Latvia, Mexico, Poland, Romania, Serbia, Slovakia, Spain, Taiwan

Regulatory

• FDA-regulated drug study