A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
4 other identifiers
interventional
60
10 countries
73
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2026
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
May 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 19, 2026
May 1, 2026
1.1 years
March 16, 2026
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Baseline, Up to Day 42
Study Arms (2)
Mirikizumab
ACTIVE COMPARATORStudy Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
LY4395089 and Mirikizumab Co-Administration
EXPERIMENTALStudy Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Interventions
Administered IV
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
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
Solare Trials
São Paulo, 01307-002, 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
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or
Eli Lilly and Company
Central Study Contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 19, 2026
Study Start
May 4, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.