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A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Sponsor: Eli Lilly and Company
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.
Official title: A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04
Completion Date
2028-03
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
LY4395089
Administered orally
Mirikizumab - Intravenous (IV)
Administered IV
Mirikizumab - Subcutaneous (SC)
Administered SC
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