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Clinical Trials in China / NCT07483073
Recruiting Phase 2

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

NCT07483073 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-05-04
Last updated
2026-09-08

Condition(s) studied

Colitis, UlcerativeCrohn Disease

Investigational drug(s) / intervention(s)

Mirikizumab - Intravenous (IV) →Mirikizumab - Subcutaneous (SC) →LY4395089 →

Mirikizumab - Intravenous (IV): Administered IV

Mirikizumab - Subcutaneous (SC): Administered SC

LY4395089: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona Suspended
Biopharma Informatic, LLC Los Angeles California Recruiting
Om Research LLC Oxnard California Recruiting
South Denver Gastroenterology Englewood Colorado Recruiting
Gastro Health Research - Miami Miami Florida Recruiting
Ezy Medical Research Miami Lakes Florida Recruiting
Atlanta Gastroenterology Associates - Peachtree Dunwoody Atlanta Georgia Recruiting
Rush University Medical Center Chicago Illinois Not Yet Recruiting
Cotton O'Neil Digestive Health Center Topeka Kansas Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Wyoming Michigan Recruiting
KAD Clinical Research St Louis Missouri Recruiting
Vector Clinical Trials Las Vegas Nevada Recruiting
One of a Kind Clinical Research Center - Kingwood Kingwood Texas Not Yet Recruiting
Southern Star Research Institute San Antonio Texas Recruiting
AZ Maria Middelares Ghent Belgium Not Yet Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
AZ Delta vzw Roeselare Belgium Not Yet Recruiting
Loema Instituto de Pesquisa Clinica Campinas Brazil Not Yet Recruiting
Fundação Universidade de Caxias do Sul (FUCS) Caxias do Sul Brazil Not Yet Recruiting
Centro Digestivo de Curitiba Curitiba Brazil Not Yet Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM Marília Brazil Not Yet Recruiting
CPHosp Medicina, Ensino e Pesquisa (CPQuali) São Paulo Brazil Not Yet Recruiting
CPCLIN São Paulo Brazil Not Yet Recruiting
BR Trials - Ensaios Clinicos e Consultoria São Paulo Brazil Not Yet Recruiting
Clínica Hepatogastro JK São Paulo Brazil Not Yet Recruiting
CEDOES Vitória Brazil Not Yet Recruiting
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) Lethbridge Canada Not Yet Recruiting
London Digestive Disease Institute London Canada Suspended
Tdda Inc. Vaughan Canada Recruiting
The Second Xiangya Hospital of Central South University Changsha China Recruiting
Changzhou Second People's Hospital Changzhou China Recruiting
The First Affiliated Hospital, Sun Yat-sen University Guangzhou China Recruiting
The Second Affiliated hospital of Zhejiang University school of medicine Hangzhou China Recruiting
Huizhou Central People's Hospital Huizhou China Recruiting
The Second Affiliated Hospital of Soochow University Suzhou China Recruiting
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university Wenzhou China Recruiting
Zhongshan Hospital Affiliated to Xiamen University Xiamen China Recruiting
Affiliated Hospital of Jiangsu University Zhenjiang China Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte Berlin Germany Not Yet Recruiting

+ 30 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07483073 on ClinicalTrials.gov ↗ ← All trials in China