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A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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)

NCT05611671•Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening
•Has evidence of UC extending at least 15 cm from the anal verge
•Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase \[JAK\] antagonists, or sphingosine-1-phosphate \[S1P\] receptor agonists)
•Subject has no prior exposure to approved or investigational anti-integrin therapies
•Agrees to abide by the study guidelines and requirements
•Capable of giving signed informed consent

Exclusion Criteria

•Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
•Has positive findings on a subjective neurological screening questionnaire
•Has a concurrent, clinically significant, serious, unstable comorbidity
•Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
•Participation in any other interventional study or received any investigational therapy within 30 days
•Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
•Unable to attend study visits or comply with study procedures

Locations (102)

Arizona Digestive Health - Sun City

Sun City, Arizona, United States

Gastro Care Institute

Lancaster, California, United States

TLC Clinical Research Inc.

Los Angeles, California, United States

Innova Clinical Trials

Coral Gables, Florida, United States

Eminat, LLC - Miramar

Miramar, Florida, United States

Robert Wood Johnson University Medical School

New Brunswick, New Jersey, United States

Great Lakes Gastroenterology

Mentor, Ohio, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Blacktown Hospital

Blacktown, Australia

Concord Repatriation General Hospital

Concord, Australia

Key Dates

Start Date

November 21, 2022

Primary Completion Date

November 28, 2024

Completion Date

August 1, 2026

Last Updated

December 15, 2025

Enrollment

280

ACTUAL participants

Conditions

Inflammatory Bowel DiseasesColitis, Ulcerative

Interventions

MORF-057

DRUG

Placebo

DRUG

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

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE2/PHASE3

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175

Colitis, Ulcerative

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

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