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Recruiting NCT07483073

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

Phase II Interventional Colitis, Ulcerative Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC), LY4395089.
Who it may be relevant to
Registry conditions: Colitis, Ulcerative, Crohn Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Brazil, Canada, China +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Mirikizumab - Intravenous (IV)
    Administered IV
  • Drug Mirikizumab - Subcutaneous (SC)
    Administered SC
  • Drug LY4395089
    Administered orally

Primary outcome measures

  • Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) [Time frame: Baseline, Up to Day 42]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • Mayo Clinic in Arizona - Scottsdale — Scottsdale
  • Biopharma Informatic, LLC — Los Angeles
  • Om Research LLC — Oxnard
  • South Denver Gastroenterology — Englewood
  • Gastro Health Research - Miami — Miami
  • Ezy Medical Research — Miami Lakes
  • Atlanta Gastroenterology Associates - Peachtree Dunwoody — Atlanta
  • Rush University Medical Center — Chicago
  • … and 6 more centers
Poland · 10 centers
  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice
  • Centrum Medyczne Oslomed — Krakow
  • Medrise Sp. z o.o. — Lublin
  • Twoja Przychodnia PCM — Poznan
  • ETG Siedlce — Siedlce
  • Twoja Przychodnia SCM — Szczecin
  • Sonomed Sp. z o. o. — Szczecin
  • WSD MEDI — Warsaw
  • … and 2 more centers
Brazil · 9 centers
  • Loema Instituto de Pesquisa Clinica — Campinas
  • Fundação Universidade de Caxias do Sul (FUCS) — Caxias do Sul
  • Centro Digestivo de Curitiba — Curitiba
  • Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
  • CPHosp Medicina, Ensino e Pesquisa (CPQuali) — São Paulo
  • CPCLIN — São Paulo
  • BR Trials - Ensaios Clinicos e Consultoria — São Paulo
  • Clínica Hepatogastro JK — São Paulo
  • … and 1 more center
China · 9 centers
  • The Second Xiangya Hospital of Central South University — Changsha
  • Changzhou Second People's Hospital — Changzhou
  • The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
  • The Second Affiliated hospital of Zhejiang University school of medicine — Hangzhou
  • Huizhou Central People's Hospital — Huizhou
  • The Second Affiliated Hospital of Soochow University — Suzhou
  • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university — Wenzhou
  • Zhongshan Hospital Affiliated to Xiamen University — Xiamen
  • … and 1 more center
Israel · 7 centers
  • Assuta Ashdod Medical Center — Ashdod
  • Rambam Health Care Campus — Haifa
  • Shaare Zedek Medical Center — Jerusalem
  • Hadassah Medical Center — Jerusalem
  • Rabin Medical Center — Petah Tikva
  • Sheba Medical Center — Ramat Gan
  • Yitzhak Shamir Medical Center — Ẕerifin
Italy · 6 centers
  • Azienda Ospedaliera Universitaria Careggi — Florence
  • Ospedale San Raffaele — Milan
  • Fondazione IRCCS San Gerardo dei Tintori — Monza
  • Ospedale Sacro Cuore Don G. Calabria — Negrar
  • Fondazione Policlinico Universitario Agostino Gemelli — Roma
  • Humanitas — Rozzano
Germany · 5 centers
  • Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin
  • Studienzentrum MVZ Dachau — Dachau
  • Studiengesellschaft Mitteldeutschland GmbH — Halle
  • St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen
  • Universitaetsklinikum Ulm — Ulm
Belgium · 4 centers
  • AZ Maria Middelares — Ghent
  • UZ Gent — Ghent
  • UZ Leuven — Leuven
  • AZ Delta vzw — Roeselare
Canada · 3 centers
  • Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) — Lethbridge
  • London Digestive Disease Institute — London
  • Tdda Inc. — Vaughan
Hungary · 3 centers
  • Geomedical Egészségügyi Központ — Budapest
  • Semmelweis Egyetem — Budapest
  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz — Tatabánya

Identifiers

NCT: NCT07483073 · 27807 · 2025-524112-11-00 · J6Z-MC-IIBD · J6Z-MC-CD01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗