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

NCT05611671 · tracked via the Priya Life Science India tracker

Sponsor

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

Phase

Phase 2

Started

2022-11-21

Last updated

2025-12-15

Condition(s) studied

Inflammatory Bowel DiseasesColitis, Ulcerative

Investigational drug(s) / intervention(s)

MORF-057Placebo

MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Placebo: Matching placebo (identical appearance to MORF-057) administered orally.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

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

Primary outcome measure(s)

Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS) — Week 12
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.

Trial sites (102)

Facility	City	Region
Arizona Digestive Health - Sun City	Sun City	Arizona
Gastro Care Institute	Lancaster	California
TLC Clinical Research Inc.	Los Angeles	California
Innova Clinical Trials	Coral Gables	Florida
Eminat, LLC - Miramar	Miramar	Florida
Robert Wood Johnson University Medical School	New Brunswick	New Jersey
Great Lakes Gastroenterology	Mentor	Ohio
The University of Texas Health Science Center at Houston	Houston	Texas
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
West Tallinn Central Hospital	Tallinn	Estonia
University of Tartu	Tartu	Estonia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet	Nice	France
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC	Tbilisi	Georgia
Curatio, Jsc	Tbilisi	Georgia
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center	Tbilisi	Georgia
LTD Aversi Clinic	Tbilisi	Georgia
Medical Center "CITO" Ltd.	Tbilisi	Georgia
LTD The First Medical Center	Tbilisi	Georgia
Charite - University Hospital Berlin	Berlin	Germany
Krankenhaus Waldfriede	Berlin	Germany
University Hospital Schleswig-Holstein	Kiel	Germany
University Hospital Ulm	Ulm	Germany
Semmelweis Medical University	Budapest	Hungary
Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology	Budapest	Hungary

+ 62 more sites — see the full list on the official registry below.

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

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

Other trials for the same condition

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis Recruiting

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05611671 on ClinicalTrials.gov ↗ ← All trials in India