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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• 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
• … и ещё 6 центров

Польша · 10 центров

• 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
• … и ещё 2 центра

Бразилия · 9 центров

• 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
• … и ещё 1 центр

Китай · 9 центров

• The Second Xiangya Hospital of Central South University — Чанша
• Changzhou Second People's Hospital — Changzhou
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• The Second Affiliated hospital of Zhejiang University school of medicine — Ханчжоу
• Huizhou Central People's Hospital — Huizhou
• The Second Affiliated Hospital of Soochow University — Сучжоу
• The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university — Wenzhou
• Zhongshan Hospital Affiliated to Xiamen University — Xiamen
• … и ещё 1 центр

Израиль · 7 центров

• 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

Италия · 6 центров

• 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

Германия · 5 центров

• Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin
• Studienzentrum MVZ Dachau — Dachau
• Studiengesellschaft Mitteldeutschland GmbH — Halle
• St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen
• Universitaetsklinikum Ulm — Ulm

Бельгия · 4 центра

• AZ Maria Middelares — Ghent
• UZ Gent — Ghent
• UZ Leuven — Leuven
• AZ Delta vzw — Roeselare

Канада · 3 центра

• Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) — Lethbridge
• London Digestive Disease Institute — London
• Tdda Inc. — Vaughan

Венгрия · 3 центра

• Geomedical Egészségügyi Központ — Budapest
• Semmelweis Egyetem — Budapest
• Komarom-Esztergom Varmegyei Szent Borbala Korhaz — Tatabánya

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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