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

NCT ID: NCT05611671

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2026-08-31

Brief 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.

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MORF-057 200 mg BID

Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.

Group Type: EXPERIMENTAL

MORF-057

Intervention Type: DRUG

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

MORF-057 100 mg BID

Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.

Group Type: EXPERIMENTAL

MORF-057

Intervention Type: DRUG

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

MORF-057 100 mg QD-M

Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.

Group Type: EXPERIMENTAL

MORF-057

Intervention Type: DRUG

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

Placebo

Participants received an oral dose of matching placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

MORF-057

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

LY4268989

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

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

Bugat Pal Korhaz

Gyöngyös, , Hungary

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, , Hungary

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, , Hungary

Javorszky Odon Korhaz

Vác, , Hungary

Fortis Memorial Research Institute(FMRI)

Gūrgaon, , India

Gleneagles Hospital

Hyderabad, , India

Sawai Man Singh Medical College Hospital (SMS Hospital)

Jaipur, , India

S R Kalla Memorial Gastro and General Hospital

Jaipur, , India

Dayanand Medical College and Hospital

Ludhiana, , India

All India Institute of Medical Sciences

New Delhi, , India

Fortis Hospital

Noida, , India

Yashoda Hospital

Secunderabad, , India

SIDS Hospital and Research Centre

Surat, , India

Government Medical College

Thiruvananthapuram, , India

Shaare Zedek Medical Center, Digestive Diseases Institute

Jerusalem, , Israel

Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases

Rehovot, , Israel

Ospedale Luigi Sacco

Milan, , Italy

Hospital of Padova

Padua, , Italy

IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali

Rozzano, , Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

IRCCS Ospedale San Raffaele

Segrate, , Italy

Liepaja Regional Hospital

Liepāja, , Latvia

Digestive Diseases Center "Gastro"

Riga, , Latvia

Pauls Stradins Clinical Univeristy Hospital

Riga, , Latvia

Republican Panevezys Hospital

Panevezys, , Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

Bydgoszcz, , Poland

St. John Paul 2nd Municipal Hospital in Elblag

Elblag, , Poland

"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company

Katowice, , Poland

Krakow Medical Center

Krakow, , Poland

IP Clinic

Lodz, , Poland

University Teaching Hospital No. 4 in Lublin

Lublin, , Poland

ETG Lublin

Lublin, , Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, , Poland

EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1

Poznan, , Poland

Twoja Przychodnia Pcm

Poznan, , Poland

Endoscopy Limited Liability Company

Sopot, , Poland

New health-CK, Kieltucki and partners g.p.

Staszów, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

H-T. Medical Center

Tychy, , Poland

Centrum Medyczne Reuma Park

Warsaw, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

EMC Medical Institute Joint Stock Company, EuroMediCare Specialist Outpatient Clinics in Wroclaw

Wroclaw, , Poland

ETG Zamość

Zamość, , Poland

Colentina Clinical Hospital

Bucharest, , Romania

Center of Diagnosis and Treatment Provita

Bucharest, , Romania

Zvezdara University Medical Center

Belgrade, , Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, , Serbia

General Hospital "Djordje Joanovic"

Zrenjanin, , Serbia

Cliniq s.r.o.

Bratislava, , Slovakia

ENDOMED s.r.o.

Košice, , Slovakia

Gastro LM s.r.o.

Prešov, , Slovakia

Dong-A University Hospital

Busan, , South Korea

Yeungnam Univeristy Medical Center

Daegu, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Changhua Christian Hospital

Changhua, , Taiwan

Chia-Yi Christian Hospital

Chiayi City, , Taiwan

Tri-Service General Hospital

Neihu Taipei, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Far Eastern Memorial Hospital

Taipei, , Taiwan

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J6E-MC-KWAD

Identifier Type: OTHER

Identifier Source: secondary_id

MORF-057-202

Identifier Type: OTHER

Identifier Source: secondary_id

2022-500953-17-00

Identifier Type: CTIS

Identifier Source: secondary_id

27398

Identifier Type: -

Identifier Source: org_study_id