A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Start Date
5/4/2026
Completion Date
3/1/2028
Summary
The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
LY4395089
Mirikizumab - Intravenous (IV)
Mirikizumab - Subcutaneous (SC)
Conditions
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