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NCT07483073

PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2028-03

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Colitis, Ulcerative Crohn Disease

Interventions

DRUG

Mirikizumab - Intravenous (IV)

Administered IV

DRUG

Mirikizumab - Subcutaneous (SC)

Administered SC

DRUG

LY4395089

Administered orally

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

Locations (72)

Biopharma Informatic, LLC

Los Angeles, California, United States

Om Research LLC

Oxnard, California, United States

South Denver Gastroenterology

Englewood, Colorado, United States

Gastro Health Research - Miami

Miami, Florida, United States

Ezy Medical Research

Miami Lakes, Florida, United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Cotton O'Neil Digestive Health Center

Topeka, Kansas, United States

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

Wyoming, Michigan, United States

KAD Clinical Research

St Louis, Missouri, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Innovo Research - Wilmington Gastroenterology Associates

Wilmington, North Carolina, United States

One of a Kind Clinical Research Center - Kingwood

Kingwood, Texas, United States

Southern Star Research Institute

San Antonio, Texas, United States

AZ Maria Middelares

Ghent, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

AZ Delta vzw

Roeselare, Belgium

Loema Instituto de Pesquisa Clinica

Campinas, Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, Brazil

Centro Digestivo de Curitiba

Curitiba, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, Brazil

CPCLIN

São Paulo, Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, Brazil

Solare Trials

São Paulo, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

CEDOES

Vitória, Brazil

London Digestive Disease Institute

London, Canada

Tdda Inc.

Vaughan, Canada

The Second Xiangya Hospital of Central South University

Changsha, China

Changzhou Second People's Hospital

Changzhou, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

The Second Affiliated hospital of Zhejiang University school of medicine

Hangzhou, China

Heilongjiang Provincial Hospital

Harbin, China

Huizhou Central People's Hospital

Huizhou, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

Wenzhou, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, China

Affiliated Hospital of Jiangsu University

Zhenjiang, China

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany

Studienzentrum MVZ Dachau

Dachau, Germany

Studiengesellschaft BSF Unternehmergesellschaft

Halle, Germany

St. Marien- und St. Annastiftskrankenhaus

Ludwigshafen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Óbudai Egészségügyi Centrum

Budapest, Hungary

Geomedical Egészségügyi Központ

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Assuta Ashdod Medical Center

Ashdod, Israel

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Israel

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Humanitas

Rozzano, Italy

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

Katowice, Poland

Oslomed Centrum Medyczne

Krakow, Poland

Medrise Sp. z o.o.

Lublin, Poland

Twoja Przychodnia PCM

Poznan, Poland

ETG Siedlce

Siedlce, Poland

Twoja Przychodnia SCM

Szczecin, Poland

Sonomed Sp. z o. o.

Szczecin, Poland

WSD MEDI

Warsaw, Poland

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

Warsaw, Poland

ETG Zamość

Zamość, Poland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)