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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Inflammatory Bowel Diseases, Colitis, Ulcerative

In brief

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).

Key facts

Study ID

NCT05611671

Run by

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

People needed

280

Starts

2022-11-21

Expected to finish

2026-08-01

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Royal Brisbane and Women's Hospital — Herston, Australia
• Fiona Stanley Hospital — Murdoch, Australia
• Mater Adult Hospital Brisbane — South Brisbane, Australia
• Order Hospital Linz Ltd. - Hospital of Sisters of Mercy — Linz, Austria
• Salzburg Regional Hospital — Salzburg, Austria
• Medical University of Vienna — Vienna, Austria
• Medical Center "Rusemed" EOOD — Rousse, Bulgaria
• University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic" — Sofia, Bulgaria
• Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda — Sofia, Bulgaria
• Second Multiprofile Hospital for Active Treatment - Sofia — Sofia, Bulgaria
• PreventaMed, s.r.o. — Olomouc, Czechia
• Clinoxus s.r.o., Outpatient Clinic Budejovicka — Prague, Czechia
• LV Venter OU — Pärnu, Estonia
• OU Innomedica — Tallinn, Estonia
• East Tallinn Central Hospital — Tallinn, Estonia
• Arizona Digestive Health - Sun City — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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