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

September 4, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • UZ Gent
        • Principal Investigator:
          • Jeroen Geldof
        • Contact:
          • Phone Number: 09 332 51 66
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • AZ Maria Middelares
        • Principal Investigator:
          • Didier Baert
        • Contact:
          • Phone Number: +3292467100
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Contact:
          • Phone Number: +3216348856
        • Principal Investigator:
          • Bram Verstockt
      • Roeselare, Belgium, 8800
        • Not yet recruiting
        • AZ Delta vzw
        • Principal Investigator:
          • Filip Baert
        • Contact:
          • Phone Number: +3251237215
  • Brazil
      • Campinas, Brazil, 13092-133
        • Not yet recruiting
        • Loema Instituto de Pesquisa Clinica
        • Principal Investigator:
          • Joaquim Simoes Neto
        • Contact:
          • Phone Number: 19 3252-5611
      • Caxias do Sul, Brazil, 95070-560
        • Not yet recruiting
        • Fundação Universidade de Caxias do Sul (FUCS)
        • Principal Investigator:
          • Eduardo Brambilla
      • Curitiba, Brazil, 80430-180
        • Not yet recruiting
        • Centro Digestivo de Curitiba
        • Contact:
          • Phone Number: +55 41 3322-1115
        • Principal Investigator:
          • Odery Ramos Júnior
      • Marília, Brazil, 17504-072
        • Not yet recruiting
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Principal Investigator:
          • FABIO TEIXEIRA
      • São Paulo, Brazil, 01228-200
        • Not yet recruiting
        • CPCLIN
        • Principal Investigator:
          • Adolpho Alexander da Silva
      • São Paulo, Brazil, 01228-000
        • Not yet recruiting
        • CPHosp Medicina, Ensino e Pesquisa (CPQuali)
        • Principal Investigator:
          • Rafael Lages
        • Contact:
          • Phone Number: +55 (11) 2776-6801
      • São Paulo, Brazil, 01236030
        • Not yet recruiting
        • BR Trials - Ensaios Clinicos e Consultoria
        • Principal Investigator:
          • Roberto da Silva
      • São Paulo, Brazil, 04077-020
        • Not yet recruiting
        • Clínica Hepatogastro JK
        • Principal Investigator:
          • Rodrigo Andrey Rocco
        • Contact:
          • Phone Number: 5511999158070
      • Vitória, Brazil, 29055450
        • Not yet recruiting
        • CEDOES
        • Principal Investigator:
          • Felipe Ferreira
        • Contact:
          • Phone Number: 5527988393435
  • Canada
      • Lethbridge, Canada, T1J 4G9
        • Not yet recruiting
        • Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
        • Principal Investigator:
          • Kaleb Marr
      • London, Canada, N6K 1M6
        • Suspended
        • London Digestive Disease Institute
      • Vaughan, Canada, L4L 4Y7
        • Recruiting
        • Tdda Inc.
        • Principal Investigator:
          • David Ford
        • Contact:
          • Phone Number: 14166500017
  • China
      • Changsha, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Principal Investigator:
          • Xuehong Wang
      • Changzhou, China, 213000
        • Recruiting
        • Changzhou Second People's Hospital
        • Principal Investigator:
          • Wenjia LIU
      • Guangzhou, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Baili Chen
      • Hangzhou, China, 310052
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Yan Chen
      • Huizhou, China, 516001
        • Recruiting
        • Huizhou Central People's Hospital
        • Principal Investigator:
          • Huixin Chen
      • Suzhou, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Wen Tang
      • Wenzhou, China, 325000
        • Recruiting
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
        • Principal Investigator:
          • yi Jiang
      • Xiamen, China, 361000
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Principal Investigator:
          • Yanyun Fan
      • Zhenjiang, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Min Xu
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte
        • Principal Investigator:
          • Christoph Jochum
        • Contact:
          • Phone Number: 004930450614031
      • Dachau, Germany, 85221
        • Not yet recruiting
        • Studienzentrum MVZ Dachau
        • Principal Investigator:
          • Wilfred Landry
        • Contact:
          • Phone Number: 004981316119311
      • Halle, Germany, 06108
        • Not yet recruiting
        • Studiengesellschaft Mitteldeutschland GmbH
        • Contact:
          • Phone Number: 00493452997626
        • Principal Investigator:
          • Lars Fechner
      • Ludwigshafen, Germany, 67067
        • Not yet recruiting
        • St. Marien- und St. Annastiftskrankenhaus
        • Principal Investigator:
          • Tanja Kuehbacher
        • Contact:
          • Phone Number: +49 (621) 5501-2224
      • Ulm, Germany, 89081
        • Not yet recruiting
        • Universitaetsklinikum Ulm
        • Principal Investigator:
          • Jochen Klaus
        • Contact:
          • Phone Number: 0497315000
  • Hungary
      • Budapest, Hungary, 1082
        • Not yet recruiting
        • Semmelweis Egyetem
        • Principal Investigator:
          • Pal Miheller
        • Contact:
          • Phone Number: 0036208250460
      • Budapest, Hungary, 1066
        • Not yet recruiting
        • Geomedical Egészségügyi Központ
        • Principal Investigator:
          • Gabor Hegede
      • Tatabánya, Hungary, 2800
        • Recruiting
        • Komárom-Esztergom Vármegyei Szent Borbála Kórház
        • Principal Investigator:
          • Samer Francis
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center
        • Principal Investigator:
          • Adi Lahat-Zok
        • Contact:
          • Phone Number: +9720723398277
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Phone Number: 972-4-7772850
        • Principal Investigator:
          • Roni Weisshof
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Phone Number: +972 26666916
        • Principal Investigator:
          • Benjamin Koslowsky
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Principal Investigator:
          • ADAR ZINGER
        • Contact:
          • Phone Number: +97225842111
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Contact:
          • Phone Number: +97239377241 (5)
        • Principal Investigator:
          • Irit Avni-Biron
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Asaf Levartovsky
        • Contact:
          • Phone Number: 0523894508
      • Ẕerifin, Israel, 7033001
        • Recruiting
        • Yitzhak Shamir Medical Center
        • Principal Investigator:
          • Vered Richter
        • Contact:
          • Phone Number: 972-8-9779066
  • Italy
      • Florence, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Principal Investigator:
          • Gabriele Dragoni
        • Contact:
          • Phone Number: +393331247273
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Silvio Danese
      • Monza, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Principal Investigator:
          • Chiara Viganò
      • Negrar, Italy, 37024
        • Not yet recruiting
        • Ospedale Sacro Cuore Don G. Calabria
        • Principal Investigator:
          • Angela Variola
      • Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli
        • Principal Investigator:
          • Franco Scaldaferri
        • Contact:
          • Phone Number: 0630154678
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Humanitas
        • Principal Investigator:
          • Alessandro Armuzzi
        • Contact:
          • Phone Number: 0282243263
  • Poland
      • Katowice, Poland, 40-600
        • Not yet recruiting
        • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
        • Principal Investigator:
          • Marek Olakowski
      • Krakow, Poland, 31-228
        • Not yet recruiting
        • Centrum Medyczne Oslomed
        • Principal Investigator:
          • Anna Drozdz
      • Lublin, Poland, 20-582
        • Not yet recruiting
        • Medrise Sp. z o.o.
        • Principal Investigator:
          • Wit Danilkiewicz
        • Contact:
          • Phone Number: +48 795 404 502
      • Poznan, Poland, 60-324
        • Not yet recruiting
        • Twoja Przychodnia PCM
        • Contact:
          • Phone Number: +48 724 444 299
        • Principal Investigator:
          • Ewa Furmanowska-Ladorska
      • Siedlce, Poland, 08-110
        • Not yet recruiting
        • ETG Siedlce
        • Principal Investigator:
          • Anna Lewandowska
      • Szczecin, Poland, 71-434
        • Not yet recruiting
        • Twoja Przychodnia SCM
        • Principal Investigator:
          • Beata Gawdis-Wojnarska
        • Contact:
          • Phone Number: 48 91 433 29 19
      • Szczecin, Poland, 71-685
        • Not yet recruiting
        • Sonomed Sp. z o. o.
        • Principal Investigator:
          • Anna Wiechowska-Kozlowska
      • Warsaw, Poland, 04-501
        • Not yet recruiting
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
          • Phone Number: 500111648
      • Warsaw, Poland, 02-786
        • Not yet recruiting
        • WSD MEDI
        • Principal Investigator:
          • Michal Krogulecki
        • Contact:
          • Phone Number: +48 504 440 092
      • Zamość, Poland, 22-400
        • Not yet recruiting
        • ETG Zamość
        • Principal Investigator:
          • Katarzyna Wojcik
        • Contact:
          • Phone Number: 48606930022
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Suspended
        • Mayo Clinic in Arizona - Scottsdale
    • California
      • Los Angeles, California, United States, 90035
        • Recruiting
        • Biopharma Informatic, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Morris Silver, MD
      • Oxnard, California, United States, 93030
        • Recruiting
        • Om Research LLC
        • Principal Investigator:
          • Karen Simon
        • Contact:
          • Phone Number: 661-388-2239
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • South Denver Gastroenterology
        • Principal Investigator:
          • Marcelo Kugelmas
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Gastro Health Research - Miami
        • Principal Investigator:
          • Lukasz Kwapisz
      • Miami Lakes, Florida, United States, 33015
        • Recruiting
        • Ezy Medical Research
        • Contact:
          • Phone Number: 786-483-8162
        • Principal Investigator:
          • Hendry Perez-Pascual
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Atlanta Gastroenterology Associates - Peachtree Dunwoody
        • Principal Investigator:
          • Nitin Gupta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Atsushi Sakuraba
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Digestive Health Center
        • Principal Investigator:
          • Curtis Baum
        • Contact:
          • Phone Number: 785-368-0477
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
        • Principal Investigator:
          • Allan Coates
    • Missouri
      • St Louis, Missouri, United States, 63123
        • Recruiting
        • KAD Clinical Research
        • Principal Investigator:
          • Adrian Di Bisceglie
        • Contact:
          • Phone Number: 314-254-3168
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Vector Clinical Trials
        • Principal Investigator:
          • Christian Stone
        • Contact:
          • Phone Number: 702-750-0000
    • Texas
      • Kingwood, Texas, United States, 77339
        • Not yet recruiting
        • One of a Kind Clinical Research Center - Kingwood
        • Principal Investigator:
          • Sushovan Guha
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute
        • Contact:
          • Phone Number: 210-581-2812
        • Principal Investigator:
          • Jeff Bullock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mirikizumab
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Drug: Mirikizumab - Intravenous (IV)
Administered IV
Other Names:
  • LY3074828
Drug: Mirikizumab - Subcutaneous (SC)
Administered SC
Other Names:
  • LY3074828
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.
Drug: Mirikizumab - Intravenous (IV)
Administered IV
Other Names:
  • LY3074828
Drug: Mirikizumab - Subcutaneous (SC)
Administered SC
Other Names:
  • LY3074828
Drug: LY4395089
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Time Frame: Baseline, Up to Day 42
Baseline, Up to Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or, Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27807
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • J6Z-MC-CD01 (Other Identifier: Eli Lilly and Company)
  • J6Z-MC-IIBD (Other Identifier: Eli Lilly and Company)
  • 2025-524112-11-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe