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
Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
• Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening
Locations
United States
Arizona
Mayo Clinic in Arizona - Scottsdale
SUSPENDED
Scottsdale
California
Biopharma Informatic, LLC
NOT_YET_RECRUITING
Los Angeles
Om Research LLC
RECRUITING
Oxnard
Colorado
South Denver Gastroenterology
RECRUITING
Englewood
Florida
Gastro Health Research - Miami
RECRUITING
Miami
Ezy Medical Research
RECRUITING
Miami Lakes
Georgia
Atlanta Gastroenterology Associates - Peachtree Dunwoody
RECRUITING
Atlanta
Illinois
Rush University Medical Center
NOT_YET_RECRUITING
Chicago
Kansas
Cotton O'Neil Digestive Health Center
RECRUITING
Topeka
Michigan
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
NOT_YET_RECRUITING
Wyoming
Missouri
KAD Clinical Research
RECRUITING
St Louis
Nevada
Vector Clinical Trials
RECRUITING
Las Vegas
Texas
One of a Kind Clinical Research Center - Kingwood
NOT_YET_RECRUITING
Kingwood
Southern Star Research Institute
RECRUITING
San Antonio
Other Locations
Belgium
AZ Maria Middelares
NOT_YET_RECRUITING
Ghent
UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
AZ Delta vzw
NOT_YET_RECRUITING
Roeselare
Brazil
Loema Instituto de Pesquisa Clinica
NOT_YET_RECRUITING
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
NOT_YET_RECRUITING
Caxias Do Sul
Centro Digestivo de Curitiba
NOT_YET_RECRUITING
Curitiba
Centro de Pesquisa Clínica de Marília - CPCLIM
NOT_YET_RECRUITING
Marília
BR Trials - Ensaios Clinicos e Consultoria
NOT_YET_RECRUITING
São Paulo
Clínica Hepatogastro JK
NOT_YET_RECRUITING
São Paulo
CPCLIN
NOT_YET_RECRUITING
São Paulo
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
NOT_YET_RECRUITING
São Paulo
CEDOES
NOT_YET_RECRUITING
Vitória
Canada
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
NOT_YET_RECRUITING
Lethbridge
London Digestive Disease Institute
SUSPENDED
London
Tdda Inc.
RECRUITING
Vaughan
China
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Changzhou Second People's Hospital
RECRUITING
Changzhou
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The Second Affiliated hospital of Zhejiang University school of medicine
RECRUITING
Hangzhou
Huizhou Central People's Hospital
RECRUITING
Huizhou
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
RECRUITING
Wenzhou
Zhongshan Hospital Affiliated to Xiamen University
RECRUITING
Xiamen
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
NOT_YET_RECRUITING
Berlin
Studienzentrum MVZ Dachau
NOT_YET_RECRUITING
Dachau
Studiengesellschaft Mitteldeutschland GmbH
NOT_YET_RECRUITING
Halle
St. Marien- und St. Annastiftskrankenhaus
NOT_YET_RECRUITING
Ludwigshafen
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Hungary
Geomedical Egészségügyi Központ
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
RECRUITING
Tatabánya
Israel
Assuta Ashdod Medical Center
RECRUITING
Ashdod
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Yitzhak Shamir Medical Center
RECRUITING
Ẕerifin
Italy
Azienda Ospedaliera Universitaria Careggi
NOT_YET_RECRUITING
Florence
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Ospedale Sacro Cuore Don G. Calabria
NOT_YET_RECRUITING
Negrar
Fondazione Policlinico Universitario Agostino Gemelli
NOT_YET_RECRUITING
Roma
Humanitas
NOT_YET_RECRUITING
Rozzano
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
NOT_YET_RECRUITING
Katowice
Centrum Medyczne Oslomed
NOT_YET_RECRUITING
Krakow
Medrise Sp. z o.o.
NOT_YET_RECRUITING
Lublin
Twoja Przychodnia PCM
NOT_YET_RECRUITING
Poznan
ETG Siedlce
NOT_YET_RECRUITING
Siedlce
Sonomed Sp. z o. o.
NOT_YET_RECRUITING
Szczecin
Twoja Przychodnia SCM
NOT_YET_RECRUITING
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NOT_YET_RECRUITING
Warsaw
WSD MEDI
NOT_YET_RECRUITING
Warsaw
ETG Zamość
NOT_YET_RECRUITING
Zamość
Contact Information
Primary
There may be multiple sites in this clinical trial. (Add This 1-877-CTLILLY (1-877-285-4559) or
clinical_inquiry_hub@lilly.com
1-317-615-4559
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2028-03
Participants
Target number of participants: 60
Treatments
Active_comparator: Mirikizumab
Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Experimental: LY4395089 and Mirikizumab Co-Administration
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV.~Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company