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NCT07483073PHASE2Recruiting

A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

Eli Lilly and Company

Start Date

5/4/2026

Completion Date

3/1/2028

Summary

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD. * For UC: * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2. * For CD: * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization * Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD * Have screening laboratory test results within the protocol specified parameters. Exclusion Criteria: * Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis * For UC - must not have a current diagnosis of CD * For CD - must not have a current diagnosis of UC * Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol * Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome * Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data * Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action * Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment * Must not have received or will need any prohibited medications for UC or CD as specified in the protocol

Interventions

DRUG

Mirikizumab - Intravenous (IV)

DRUG

Mirikizumab - Subcutaneous (SC)

DRUG

LY4395089

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Conditions

Colitis, UlcerativeCrohn Disease

Locations

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona 85259

United States

Biopharma Informatic, LLC

Los Angeles, California 90035

United States

Om Research LLC

Oxnard, California 93030

United States

South Denver Gastroenterology

Englewood, Colorado 80113

United States

Gastro Health Research - Miami

Miami, Florida 33176

United States

Ezy Medical Research

Miami Lakes, Florida 33015

United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody

Atlanta, Georgia 30342

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Cotton O'Neil Digestive Health Center

Topeka, Kansas 66606

United States

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

Wyoming, Michigan 49519

United States

KAD Clinical Research

St Louis, Missouri 63123

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Innovo Research - Wilmington Gastroenterology Associates

Wilmington, North Carolina 28403

United States

One of a Kind Clinical Research Center - Kingwood

Kingwood, Texas 77339

United States

Southern Star Research Institute

San Antonio, Texas 78229

United States

AZ Maria Middelares

Ghent, 9000

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

AZ Delta vzw

Roeselare, 8800

Belgium

Loema Instituto de Pesquisa Clinica

Campinas, 13092-133

Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, 95070-560

Brazil

Centro Digestivo de Curitiba

Curitiba, 80430-180

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, 01228-000

Brazil

CPCLIN

São Paulo, 01228-200

Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, 01236030

Brazil

Clínica Hepatogastro JK

São Paulo, 04077-020

Brazil

CEDOES

Vitória, 29055450

Brazil

Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)

Lethbridge, T1J 4G9

Canada

London Digestive Disease Institute

London, N6K 1M6

Canada

Tdda Inc.

Vaughan, L4L 4Y7

Canada

The Second Xiangya Hospital of Central South University

Changsha, 410011

China

Changzhou Second People's Hospital

Changzhou, 213000

China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080

China

The Second Affiliated hospital of Zhejiang University school of medicine

Hangzhou, 310052

China

Huizhou Central People's Hospital

Huizhou, 516001

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

Wenzhou, 325000

China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, 361000

China

Affiliated Hospital of Jiangsu University

Zhenjiang, 212000

China

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117

Germany

Studienzentrum MVZ Dachau

Dachau, 85221

Germany

Studiengesellschaft BSF Unternehmergesellschaft

Halle, 06108

Germany

St. Marien- und St. Annastiftskrankenhaus

Ludwigshafen, 67067

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Geomedical Egészségügyi Központ

Budapest, 1066

Hungary

Semmelweis Egyetem

Budapest, 1082

Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800

Hungary

Assuta Ashdod Medical Center

Ashdod, 7747629

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 5262100

Israel

Yitzhak Shamir Medical Center

Ẕerifin, 7033001

Israel

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, 20900

Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, 37024

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Humanitas

Rozzano, 20089

Italy

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

Katowice, 40-600

Poland

Oslomed Centrum Medyczne

Krakow, 31-228

Poland

Medrise Sp. z o.o.

Lublin, 20-582

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

ETG Siedlce

Siedlce, 08-110

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