RecruitingRecruiting
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
NCT07483073 · Eli Lilly and Company
In plain English
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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
About this study
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 criteria
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 design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-04
Estimated completion: 2028-03
Last updated: 2026-06-04
Interventions
Drug: Mirikizumab - Intravenous (IV)Drug: Mirikizumab - Subcutaneous (SC)Drug: LY4395089
Primary outcomes
- • Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) (Baseline, Up to Day 42)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or · contact · clinical_inquiry_hub@lilly.com · 1-317-615-4559
InvestigatorContact Lilly at 1-877-CTLILLY (1-877-285-4559) or · study_director, Eli Lilly and Company
All locations (72)
Mayo Clinic in Arizona - ScottsdaleNot Yet Recruiting
Scottsdale, Arizona, United States
Biopharma Informatic, LLCRecruiting
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South Denver GastroenterologyNot Yet Recruiting
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Gastro Health Research - MiamiNot Yet Recruiting
Miami, Florida, United States
Ezy Medical ResearchRecruiting
Miami Lakes, Florida, United States
Atlanta Gastroenterology Associates - Peachtree DunwoodyRecruiting
Atlanta, Georgia, United States
Rush University Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
Cotton O'Neil Digestive Health CenterRecruiting
Topeka, Kansas, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterRecruiting
Wyoming, Michigan, United States
KAD Clinical ResearchNot Yet Recruiting
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Las Vegas, Nevada, United States
Innovo Research - Wilmington Gastroenterology AssociatesNot Yet Recruiting
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One of a Kind Clinical Research Center - KingwoodNot Yet Recruiting
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Southern Star Research InstituteRecruiting
San Antonio, Texas, United States
AZ Maria MiddelaresNot Yet Recruiting
Ghent, Belgium
UZ GentNot Yet Recruiting
Ghent, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
AZ Delta vzwNot Yet Recruiting
Roeselare, Belgium
Loema Instituto de Pesquisa ClinicaNot Yet Recruiting
Campinas, Brazil
Fundação Universidade de Caxias do Sul (FUCS)Not Yet Recruiting
Caxias do Sul, Brazil
Centro Digestivo de CuritibaNot Yet Recruiting
Curitiba, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMNot Yet Recruiting
Marília, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)Not Yet Recruiting
São Paulo, Brazil
CPCLINNot Yet Recruiting
São Paulo, Brazil
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São Paulo, Brazil
Clínica Hepatogastro JKNot Yet Recruiting
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CEDOESNot Yet Recruiting
Vitória, Brazil
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)Not Yet Recruiting
Lethbridge, Canada
London Digestive Disease InstituteNot Yet Recruiting
London, Canada
Tdda Inc.Not Yet Recruiting
Vaughan, Canada
The Second Xiangya Hospital of Central South UniversityNot Yet Recruiting
Changsha, China
Changzhou Second People's HospitalNot Yet Recruiting
Changzhou, China
The First Affiliated Hospital, Sun Yat-sen UniversityNot Yet Recruiting
Guangzhou, China
The Second Affiliated hospital of Zhejiang University school of medicineNot Yet Recruiting
Hangzhou, China
Huizhou Central People's HospitalNot Yet Recruiting
Huizhou, China
The Second Affiliated Hospital of Soochow UniversityNot Yet Recruiting
Suzhou, China
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical universityNot Yet Recruiting
Wenzhou, China
Zhongshan Hospital Affiliated to Xiamen UniversityNot Yet Recruiting
Xiamen, China
Affiliated Hospital of Jiangsu UniversityNot Yet Recruiting
Zhenjiang, China
Charité Universitaetsmedizin Berlin - Campus MitteNot Yet Recruiting
Berlin, Germany
Studienzentrum MVZ DachauNot Yet Recruiting
Dachau, Germany
Studiengesellschaft BSF UnternehmergesellschaftNot Yet Recruiting
Halle, Germany
St. Marien- und St. AnnastiftskrankenhausNot Yet Recruiting
Ludwigshafen, Germany
Universitaetsklinikum UlmNot Yet Recruiting
Ulm, Germany
Geomedical Egészségügyi KözpontNot Yet Recruiting
Budapest, Hungary
Semmelweis EgyetemNot Yet Recruiting
Budapest, Hungary
Komarom-Esztergom Varmegyei Szent Borbala KorhazNot Yet Recruiting
Tatabánya, Hungary
Assuta Ashdod Medical CenterNot Yet Recruiting
Ashdod, Israel
Rambam Health Care CampusNot Yet Recruiting
Haifa, Israel
Shaare Zedek Medical CenterNot Yet Recruiting
Jerusalem, Israel
Hadassah Medical CenterNot Yet Recruiting
Jerusalem, Israel
Rabin Medical CenterNot Yet Recruiting
Petah Tikva, Israel
Sheba Medical CenterNot Yet Recruiting
Ramat Gan, Israel
Yitzhak Shamir Medical CenterNot Yet Recruiting
Ẕerifin, Israel
Azienda Ospedaliera Universitaria CareggiNot Yet Recruiting
Florence, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
Fondazione IRCCS San Gerardo dei TintoriNot Yet Recruiting
Monza, Italy
Ospedale Sacro Cuore Don G. CalabriaNot Yet Recruiting
Negrar, Italy
Fondazione Policlinico Universitario Agostino GemelliNot Yet Recruiting
Roma, Italy
HumanitasNot Yet Recruiting
Rozzano, Italy
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział LiberoNot Yet Recruiting
Katowice, Poland
Oslomed Centrum MedyczneNot Yet Recruiting
Krakow, Poland
Medrise Sp. z o.o.Not Yet Recruiting
Lublin, Poland
Twoja Przychodnia PCMNot Yet Recruiting
Poznan, Poland
ETG SiedlceNot Yet Recruiting
Siedlce, Poland
Twoja Przychodnia SCMNot Yet Recruiting
Szczecin, Poland
Sonomed Sp. z o. o.Not Yet Recruiting
Szczecin, Poland
WSD MEDINot Yet Recruiting
Warsaw, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśNot Yet Recruiting
Warsaw, Poland
ETG ZamośćNot Yet Recruiting
Zamość, Poland