NCT05291689

A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (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 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 Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

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.

Timeline

• Start date: 2022-04-13
• Primary completion: 2023-10-18
• Completion: 2025-02-19
• First posted: 2022-03-23
• Last updated: 2026-03-11
• Results posted: 2024-11-26

Locations

17 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study