NCT05611671

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

A Phase 2b, 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 Ulcerative Colitis (EMERALD-2)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• 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 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Detailed description

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.

Conditions

• Inflammatory Bowel Diseases
• Colitis, Ulcerative

Interventions

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

Timeline

• Start date: 2022-11-21
• Primary completion: 2024-11-28
• Completion: 2026-08-01
• First posted: 2022-11-10
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

102 sites across 21 countries: United States, Australia, Austria, Bulgaria, Czechia, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study