A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

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

Overview

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.

Interventions

• Drug LY4395089
  Administered orally
• Drug Mirikizumab - Intravenous (IV)
  Administered IV
• Drug Mirikizumab - Subcutaneous (SC)
  Administered SC

Primary outcome measures

• Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response [Time frame: Baseline, Up to Week 12]

Secondary outcome measures (2)

• Percentage of Participants who Achieve Clinical Remission [Time frame: Baseline, Up to Week 12]
• Percent Change from Baseline in Fecal Calprotectin [Time frame: Baseline, Up to Week 12]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Participants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:

• Must not have a hepatic disease
• Must not have a history of any other bone disease that affects bone metabolism
• Must not have had any of the following within the past 180 days before screening:

• acute myocardial infarction
• cerebrovascular incident
• hospitalization for unstable angina
• hospitalization due to congestive heart failure, or
• coronary revascularization
• Must not have received or will need any other prohibited medications as specified in the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 14 centers

• Mayo Clinic in Arizona - Scottsdale — Scottsdale
• Biopharma Informatic, LLC — Los Angeles
• Om Research LLC — Oxnard
• South Denver Gastroenterology — Englewood
• Gastro Health Research - Miami — Miami
• Ezy Medical Research — Miami Lakes
• Atlanta Gastroenterology Associates - Peachtree Dunwoody — Atlanta
• Rush University Medical Center — Chicago
• … and 6 more centers

Poland · 10 centers

• Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice
• Centrum Medyczne Oslomed — Krakow
• Medrise Sp. z o.o. — Lublin
• Twoja Przychodnia PCM — Poznan
• ETG Siedlce — Siedlce
• Twoja Przychodnia SCM — Szczecin
• Sonomed Sp. z o. o. — Szczecin
• WSD MEDI — Warsaw
• … and 2 more centers

Brazil · 9 centers

• Loema Instituto de Pesquisa Clinica — Campinas
• Fundação Universidade de Caxias do Sul (FUCS) — Caxias do Sul
• Centro Digestivo de Curitiba — Curitiba
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
• CPHosp Medicina, Ensino e Pesquisa (CPQuali) — São Paulo
• CPCLIN — São Paulo
• BR Trials - Ensaios Clinicos e Consultoria — São Paulo
• Clínica Hepatogastro JK — São Paulo
• … and 1 more center

China · 9 centers

• The Second Xiangya Hospital of Central South University — Changsha
• Changzhou Second People's Hospital — Changzhou
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
• The Second Affiliated hospital of Zhejiang University school of medicine — Hangzhou
• Huizhou Central People's Hospital — Huizhou
• The Second Affiliated Hospital of Soochow University — Suzhou
• The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university — Wenzhou
• Zhongshan Hospital Affiliated to Xiamen University — Xiamen
• … and 1 more center

Israel · 7 centers

• Assuta Ashdod Medical Center — Ashdod
• Rambam Health Care Campus — Haifa
• Shaare Zedek Medical Center — Jerusalem
• Hadassah Medical Center — Jerusalem
• Rabin Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan
• Yitzhak Shamir Medical Center — Ẕerifin

Italy · 6 centers

• Azienda Ospedaliera Universitaria Careggi — Florence
• Ospedale San Raffaele — Milan
• Fondazione IRCCS San Gerardo dei Tintori — Monza
• Ospedale Sacro Cuore Don G. Calabria — Negrar
• Fondazione Policlinico Universitario Agostino Gemelli — Roma
• Humanitas — Rozzano

Germany · 5 centers

• Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin
• Studienzentrum MVZ Dachau — Dachau
• Studiengesellschaft Mitteldeutschland GmbH — Halle
• St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen
• Universitaetsklinikum Ulm — Ulm

Belgium · 4 centers

• AZ Maria Middelares — Ghent
• UZ Gent — Ghent
• UZ Leuven — Leuven
• AZ Delta vzw — Roeselare

Canada · 3 centers

• Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) — Lethbridge
• London Digestive Disease Institute — London
• Tdda Inc. — Vaughan

Hungary · 3 centers

• Geomedical Egészségügyi Központ — Budapest
• Semmelweis Egyetem — Budapest
• Komarom-Esztergom Varmegyei Szent Borbala Korhaz — Tatabánya

Identifiers

NCT: NCT07483099 · 27810 · J6Z-MC-CD01 · J6Z-MC-IIBD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗