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

NCT05611671 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-12-15

Study results available
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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).

Conditions

  • Inflammatory Bowel Diseases
  • Colitis, Ulcerative

Interventions

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.

Sponsors & Collaborators

  • Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2024-11-28
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611671 on ClinicalTrials.gov