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A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2026-05-22

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-18
Primary Completion
2028-09-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Kazakhstan
  • Latvia
  • Mexico
  • Moldova
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06226883 on ClinicalTrials.gov