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NCT07186101PHASE2Recruiting

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

Eli Lilly and Company

Start Date

11/10/2025

Completion Date

3/1/2029

Summary

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC * Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1. * Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization * Are up-to-date on colorectal cancer surveillance per local society guidelines * Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications: * Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US) NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US) * Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: * a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for * mirikizumab. * Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib * sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod Exclusion Criteria: * Have a current diagnosis of * Crohn's disease * Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or * primary sclerosing cholangitis * Have had or will need bowel resection or intestinal or intra-abdominal surgery * Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic * Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply * Have a current or recent acute, active infection

Interventions

DRUG

LY4268989

DRUG

Mirikizumab

DRUG

LY4268989 Placebo

Interested in This Trial?

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Conditions

Ulcerative Colitis

Locations

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona 85259

United States

Clinnova Research - Anaheim

Anaheim, California 92805

United States

Om Research LLC

Lancaster, California 93534

United States

Biopharma Informatic, LLC

Los Angeles, California 90035

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

NeoClinical Research

Hialeah, Florida 33016

United States

Encore Borland-Groover Clinical Research

Jacksonville, Florida 32256

United States

Clinical Research of Osceola

Kissimmee, Florida 34741

United States

Florida Research Institute

Lakewood Rch, Florida 34211

United States

Alliance Medical Research

Lighthouse PT, Florida 33064

United States

Atlantic Medical Research

Margate, Florida 33063

United States

Digestive and Liver Center of Florida

Orlando, Florida 32825

United States

Center for Gastrointestinal Health - Fairview Heights

Belleville, Illinois 62223

United States

Northwestern University

Chicago, Illinois 60611

United States

Midtown Gastroenterology and Liver Disease

Des Plaines, Illinois 60016

United States

GI Alliance - Glenview

Glenview, Illinois 60026

United States

Gi Alliance - Gurnee

Gurnee, Illinois 60031

United States

Gastroenterology Health Partners

New Albany, Indiana 47150

United States

Gastroenterology Health Partners

Louisville, Kentucky 40218

United States

Brigham and Women's Hospital

Boston, Massachusetts 02215

United States

Clinical Research Institute of Michigan, LLC

Clinton Township, Michigan 48038

United States

GI Associates - GIA and Endoscopy Center - Flowood

Flowood, Mississippi 39232

United States

Digestive Disease Medicine of Central New York

Utica, New York 13502

United States

Dayton Gastroenterology, LLC

Dayton, Ohio 45415

United States

University Gastroenterology - Providence - West River Street

Providence, Rhode Island 02904

United States

Gastroenterology Associates, P.A. of Greenville

Greenville, South Carolina 29607

United States

Gastro One - Walnut Run Road

Cordova, Tennessee 38018

United States

Texas Digestive Disease Consultants - Cedar Park

Cedar Park, Texas 78613

United States

GI Alliance - Dallas - Gaston Avenue

Dallas, Texas 75246

United States

GI Alliance - Fort Worth

Fort Worth, Texas 76104

United States

GI Alliance - Garland

Garland, Texas 75044

United States

GI Alliance - Lubbock

Lubbock, Texas 79410

United States

Southern Star Research Institute

San Antonio, Texas 78229

United States

Tyler Research Institute

Tyler, Texas 75701

United States

GI Alliance-Webster

Webster, Texas 77598

United States

Care Access - Ogden

Ogden, Utah 84403

United States

Clinical Research Partners, LLC

Richmond, Virginia 23226

United States

GI Alliance - Richmond

Richmond, Virginia 23229

United States

Carilion Clinic

Roanoke, Virginia 24014

United States

Washington Gastroenterology - Bellevue

Bellevue, Washington 98004

United States

Medizinische Universität Wien

Vienna, 1090

Austria

Chronos Pesquisa Clínica

Brasília, 72145-450

Brazil

CAEP - Synvia Labs

Campinas, 13087-567

Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, 95070-560

Brazil

Centro Digestivo de Curitiba

Curitiba, 80430-180

Brazil

Galileo Medical Research

Juiz de Fora, 36033-318

Brazil

NewData Clinical Research - Maceió

Maceió, 57020-360

Brazil

Hospital Ernesto Dornelles

Porto Alegre, 90160-092

Brazil

Centro Internacional de Pesquisa Clínica (CIPES)

São José dos Campos, 12230-001

Brazil

CPQuali Pesquisa Clínica

São Paulo, 01228-000

Brazil

Solare Trials

São Paulo, 01307-002

Brazil

Hospital Santa Catarina - Paulista

São Paulo, 01310-000

Brazil

Clínica Hepatogastro JK

São Paulo, 04543-011

Brazil

BRA - Clínica Médica e Terapia Assistida

Tajaí, 88301-220

Brazil

Universidade Federal Do Piaui - Campos Universitario

Teresina, 64049-550

Brazil

Charlton Digestive Disease Centre

Hamilton, L8N 1Y2

Canada

London Health Sciences Centre

London, N6A 5W9

Canada

London Digestive Disease Institute

London, N6K 1M6

Canada

West GTA Research Inc.

Mississauga, L5M 2S4

Canada

C.I.C. Mauricie inc.

Trois-Rivières, G8T 7A1

Canada

Changzhou Second People's Hospital

Changzhou, 213000

China

Chongqing General Hospital

Chongqing, 401147

China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, 350005

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, 310018

China

First Affiliated Hospital of Kunming Medical University

Kunming, 650032

China

Jiangsu Province Hospital

Nanjing, 210029

China

The Affiliated Hospital of Qingdao University

Qingdao, 266003

China

Shengjing Hospital of China Medical University

Shenyang, 110004

China

The Second Afilliated Hospital of Hebei Medical University

Shijiazhuang, 050000

China

Taian City Central Hospital

Taian, 271000

China

Wuhan Union Hospital

Wuhan, 430022

China

Wuxi People's Hospital

Wuxi, 214023

China

Herlev and Gentofte Hospital

Copenhagen, 2730

Denmark

Aalborg Universitetshospital, Syd

Gistrup, 9260

Denmark

Odense Universitetshospital

Odense, 5000

Denmark

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117

Germany

Studienzentrum MVZ Dachau

Dachau, 85221

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Universitätsklinikum Regensburg

Regensburg, 93053

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

Békéscsaba, 5600

Hungary

Óbudai Egészségügyi Centrum

Budapest, 1036

Hungary

Semmelweis Egyetem

Budapest, 1088

Hungary

Pannónia Magánorvosi Centrum

Budapest, 1136

Hungary

Clinexpert Gyöngyös

Gyöngyös, 3200

Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800

Hungary

Jávorszky Ödön Kórház

Vác, 2600

Hungary

Sardar Vallabhbhai Patel Institute of Medical Sciences and Research

Ahmedabad, 380006

India

Rajiv Gandhi Government General Hospital

Chennai, 600003

India

Ashwin Hospital

Coimbatore, 641012

India

Sushruta Multispeciality Hospital & Research Centre

Hubli, 580021

India

Mahavir Hospital & Research Centre - Hyderabad

Hyderabad, 500004

India

All India Institute of Medical Sciences

New Delhi, 110029

India

Medipoint Hospitals Pvt. Ltd.

Pune, 411007

India

Shree Giriraj Multispeciality Hospital

Rajkot, 360005

India

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Humanitas

Rozzano, 20089

Italy

Fukuoka University Hospital

Fukuoka, 814-0180

Japan

Gokeikai Ofuna Chuo Hospital

Kamakura, 247-0056

Japan

Tsujinaka Hospital - Kashiwanoha

Kashiwa, 277-0871

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540-0006

Japan

Toho University Sakura Medical Center

Sakura, 285-8741

Japan

Sapporo Tokushukai Hospital

Sapporo, 004-0041

Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000

Mexico

Boca Clinical Trials Mexico S.C.

Guadajalara, 44600

Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, 44650

Mexico

Centro de Investigación y Gastroenterología - S.C.

Mexico City, 03330

Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, 04100

Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080

Mexico

Servicios de Oncología Médica Integral - Monterrey

San Pedro Garza García, 66220

Mexico

Scientia Investigacion Clinica S.C.

Tijuana, 22105

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

Medimanage Research

Tlalpan, 14050

Mexico

FAICIC S. de R.L. de C.V.

Veracruz, 91900

Mexico

Radboudumc

Nijmegen, 6525 GA

Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC

Netherlands

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, 40-600

Poland

IRMED

Piotrkow Trybunalski, 97-300

Poland

Pratia Poznań

Poznan, 60-192

Poland

Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

Poznan, 60-354

Poland

Twoja Przychodnia SCM

Szczecin, 71-434

Poland

Sonomed Sp. z o. o.

Szczecin, 71-685

Poland

WSD MEDI

Warsaw, 02-786

Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, 04-501

Poland

ETG Zamość

Zamość, 22-400

Poland

Delta Health Care

Bucharest, 014142

Romania

Spitalul Clinic Colentina

Bucharest, 020125

Romania

Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

Constanța, 900591

Romania

Spital Judetean de Urgenta

Satu Mare, 440055

Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

Timișoara, 300002

Romania

Centro Médico Teknon

Barcelona, 08022

Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, 28942

Spain

Hospital de Cabueñes

Gijón, 33394

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Adana City Hospital

Adana,

Turkey (Türkiye)

Gazi University Health Research and Application Center Gazi Hospital

Ankara, 06560

Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi

Antalya, 07100

Turkey (Türkiye)

Eskisehir Osmangazi University

Eskişehir, 26480

Turkey (Türkiye)

Mustafa Kemal Universitesi

Hatay, 31030

Turkey (Türkiye)

Kocaeli University Medical Faculty Hospital

İzmit, 41380

Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

Malatya, 44280

Turkey (Türkiye)

Mersin University

Mersin, 33110

Turkey (Türkiye)

Dicle Üniversitesi

Sur, 21200

Turkey (Türkiye)