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A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease Phase 2 60 Master Protocol

Not yet recruiting
Clinical Trial NCT07483073 is designed to study Treatment for Colitis, Ulcerative, Crohn Disease. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on April 1, 2026 until the study accrues 60 participants. Led by Eli Lilly and Company, this study is expected to complete by March 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 19, 2026.
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.
Official Title

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

Conditions
Colitis, UlcerativeCrohn Disease
Other Study IDs
  • 27807
  • 2025-524112-11-00 (EU Study (CTIS) Number)
  • J6Z-MC-IIBD (Other Identifier) (Eli Lilly and Company)
  • J6Z-MC-CD01 (Other Identifier) (Eli Lilly and Company)
NCT ID Number
NCT07483073
Start Date (Actual)
2026-04
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-03
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorMirikizumab
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Mirikizumab - Intravenous (IV)
Administered IV
Mirikizumab - Subcutaneous (SC)
Administered SC
ExperimentalLY4395089 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.
Mirikizumab - Intravenous (IV)
Administered IV
Mirikizumab - Subcutaneous (SC)
Administered SC
LY4395089
Administered orally
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Baseline, Up to Day 42
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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.

  • 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

Eli Lilly and Company logoEli Lilly and Company362 active studies to explore
Study Central Contact
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
72 Study Locations in 10 Countries

California

Biopharma Informatic, LLC, Los Angeles, California, 90035, United States
Contact, (281) 944-3610
Morris Silver, MD, Principal Investigator
Om Research LLC, Oxnard, California, 93030, United States
Contact, 661.388.2239
Karen Simon, Principal Investigator

Colorado

South Denver Gastroenterology, Englewood, Colorado, 80113, United States
Marcelo Kugelmas, Principal Investigator

Florida

Gastro Health Research - Miami, Miami, Florida, 33176, United States
Lukasz Kwapisz, Principal Investigator
Ezy Medical Research, Miami Lakes, Florida, 33015, United States
Contact, 7864838162
Hendry Perez-Pascual, Principal Investigator

Georgia

Atlanta Gastroenterology Associates - Peachtree Dunwoody, Atlanta, Georgia, 30342, United States
Nitin Gupta, Principal Investigator

Illinois

Rush University Medical Center, Chicago, Illinois, 60612, United States
Atsushi Sakuraba, Principal Investigator

Kansas

Cotton O'Neil Digestive Health Center, Topeka, Kansas, 66606, United States
Contact, 785-270-4800
Curtis Baum, Principal Investigator

Michigan

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center, Wyoming, Michigan, 49519, United States
Allan Coates, Principal Investigator

Missouri

KAD Clinical Research, St Louis, Missouri, 63123, United States
Contact, 1-314-254-3168
Adrian Di Bisceglie, Principal Investigator

Nevada

Vector Clinical Trials, Las Vegas, Nevada, 89128, United States
Contact, 7027500000
Christian Stone, Principal Investigator

North Carolina

Innovo Research - Wilmington Gastroenterology Associates, Wilmington, North Carolina, 28403, United States
William King, Principal Investigator

Texas

One of a Kind Clinical Research Center - Kingwood, Kingwood, Texas, 77339, United States
Sushovan Guha, Principal Investigator
Southern Star Research Institute, San Antonio, Texas, 78229, United States
Contact, 210-581-2812
Jeff Bullock, Principal Investigator
London Digestive Disease Institute, London, N6K 1M6, Canada
Vipul Jairath, Principal Investigator
Tdda Inc., Vaughan, L4L 4Y7, Canada
Contact, 14166500017
David Ford, Principal Investigator
AZ Maria Middelares, Ghent, 9000, Belgium
Contact, +3292467100
Didier Baert, Principal Investigator
UZ Gent, Ghent, 9000, Belgium
Contact, 09 332 51 66
Jeroen Geldof, Principal Investigator
UZ Leuven, Leuven, 3000, Belgium
Contact, +3216348856
Bram Verstockt, Principal Investigator
AZ Delta vzw, Roeselare, 8800, Belgium
Contact, +3251237215
Filip Baert, Principal Investigator
Loema Instituto de Pesquisa Clinica, Campinas, 13092-133, Brazil
Contact, 19 3252-5611
Joaquim Simoes Neto, Principal Investigator
Fundação Universidade de Caxias do Sul (FUCS), Caxias do Sul, 95070-560, Brazil
Eduardo Brambilla, Principal Investigator
Centro Digestivo de Curitiba, Curitiba, 80430-180, Brazil
Contact, +55 41 3322-1115
Odery Ramos Júnior, Principal Investigator
Centro de Pesquisa Clínica de Marília - CPCLIM, Marília, 17504-072, Brazil
FABIO TEIXEIRA, Principal Investigator
CPHosp Medicina, Ensino e Pesquisa (CPQuali), São Paulo, 01228-000, Brazil
Contact, +55 (11) 2776-6801
Rafael Lages, Principal Investigator
CPCLIN, São Paulo, 01228-200, Brazil
Adolpho Alexander da Silva, Principal Investigator
BR Trials - Ensaios Clinicos e Consultoria, São Paulo, 01236030, Brazil
Roberto da Silva, Principal Investigator
Solare Trials, São Paulo, 01307-002, Brazil
Marjorie Argollo, Principal Investigator
Clínica Hepatogastro JK, São Paulo, 04543-011, Brazil
Contact, 5511999158070
Rodrigo Andrey Rocco, Principal Investigator
CEDOES, Vitória, 29055450, Brazil
Contact, 5527988393435
Felipe Ferreira, Principal Investigator
The Second Xiangya Hospital of Central South University, Changsha, 410011, China
Xuehong Wang, Principal Investigator
Changzhou Second People's Hospital, Changzhou, 213000, China
Wenjia LIU, Principal Investigator
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
Baili Chen, Principal Investigator
The Second Affiliated hospital of Zhejiang University school of medicine, Hangzhou, 310052, China
Yan Chen, Principal Investigator
Heilongjiang Provincial Hospital, Harbin, 150036, China
Xiaomei Sun, Principal Investigator
Huizhou Central People's Hospital, Huizhou, 516001, China
Huixin Chen, Principal Investigator
The Second Affiliated Hospital of Soochow University, Suzhou, 215004, China
Wen Tang, Principal Investigator
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university, Wenzhou, 325000, China
yi Jiang, Principal Investigator
Zhongshan Hospital Affiliated to Xiamen University, Xiamen, 361000, China
Yanyun Fan, Principal Investigator
Affiliated Hospital of Jiangsu University, Zhenjiang, 212000, China
Min Xu, Principal Investigator
Charité Universitaetsmedizin Berlin - Campus Mitte, Berlin, 10117, Germany
Contact, 004930450614031
Christoph Jochum, Principal Investigator
Studienzentrum MVZ Dachau, Dachau, 85221, Germany
Contact, 004981316119311
Wilfred Landry, Principal Investigator
Studiengesellschaft BSF Unternehmergesellschaft, Halle, 06108, Germany
Contact, 00493452997626
Lars Fechner, Principal Investigator
St. Marien- und St. Annastiftskrankenhaus, Ludwigshafen, 67067, Germany
Contact, +49 (621) 5501-2224
Tanja Kuehbacher, Principal Investigator
Universitaetsklinikum Ulm, Ulm, 89081, Germany
Contact, 0497315000
Jochen Klaus, Principal Investigator
Óbudai Egészségügyi Centrum, Budapest, 1036, Hungary
Contact, 06309399575
Tamás Toth, Principal Investigator
Geomedical Egészségügyi Központ, Budapest, 1066, Hungary
Gabor Hegede, Principal Investigator
Semmelweis Egyetem, Budapest, 1082, Hungary
Contact, 0036208250460
Pal Miheller, Principal Investigator
Komarom-Esztergom Varmegyei Szent Borbala Korhaz, Tatabánya, 2800, Hungary
Samer Francis, Principal Investigator
Assuta Ashdod Medical Center, Ashdod, 7747629, Israel
Contact, +9720723398277
Adi Lahat-Zok, Principal Investigator
Rambam Health Care Campus, Haifa, 3109601, Israel
Contact, 972-4-7772850
Roni Weisshof, Principal Investigator
Shaare Zedek Medical Center, Jerusalem, 9103102, Israel
Contact, +972 26666916
Benjamin Koslowsky, Principal Investigator
Hadassah Medical Center, Jerusalem, 9112001, Israel
Contact, +97225842111
ADAR ZINGER, Principal Investigator
Rabin Medical Center, Petah Tikva, 4941492, Israel
Contact, +97239377241 (5)
Irit Avni-Biron, Principal Investigator
Sheba Medical Center, Ramat Gan, 5262100, Israel
Contact, 0523894508
Asaf Levartovsky, Principal Investigator
Yitzhak Shamir Medical Center, Ẕerifin, 7033001, Israel
Contact, 972-8-9779066
Vered Richter, Principal Investigator
Azienda Ospedaliera Universitaria Careggi, Florence, 50134, Italy
Contact, +393331247273
Gabriele Dragoni, Principal Investigator
Ospedale San Raffaele, Milan, 20132, Italy
Silvio Danese, Principal Investigator
Fondazione IRCCS San Gerardo dei Tintori, Monza, 20900, Italy
Chiara Viganò, Principal Investigator
Ospedale Sacro Cuore Don G. Calabria, Negrar, 37024, Italy
Angela Variola, Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli, Roma, 00168, Italy
Contact, 0630154678
Franco Scaldaferri, Principal Investigator
Humanitas, Rozzano, 20089, Italy
Contact, 0282243263
Alessandro Armuzzi, Principal Investigator
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero, Katowice, 40-600, Poland
Marek Olakowski, Principal Investigator
Oslomed Centrum Medyczne, Krakow, 31-228, Poland
Anna Drozdz, Principal Investigator
Medrise Sp. z o.o., Lublin, 20-582, Poland
Contact, +48 795 404 502
Wit Danilkiewicz, Principal Investigator
Twoja Przychodnia PCM, Poznan, 60-324, Poland
Contact, +48 724 444 299
Ewa Furmanowska-Ladorska, Principal Investigator
ETG Siedlce, Siedlce, 08-110, Poland
Anna Lewandowska, Principal Investigator
Twoja Przychodnia SCM, Szczecin, 71-434, Poland
Contact, 48 91 433 29 19
Beata Gawdis-Wojnarska, Principal Investigator
Sonomed Sp. z o. o., Szczecin, 71-685, Poland
Anna Wiechowska-Kozlowska, Principal Investigator
WSD MEDI, Warsaw, 02-786, Poland
Contact, +48 504 440 092
Michal Krogulecki, Principal Investigator
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś, Warsaw, 04-501, Poland
Contact, 500111648
Jaroslaw Kierkus, Principal Investigator
ETG Zamość, Zamość, 22-400, Poland
Contact, 48721055855
Katarzyna Wojcik, Principal Investigator