A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Официальное название

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Обзор

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Вмешательства

• Препарат Guselkumab
  Guselkumab will be administered.
• Препарат Risankizumab
  Risankizumab will be administered.

Первичные конечные точки

• Number of Participants with Deep Remission at Week 52 [Срок оценки: At Week 52]

Вторичные конечные точки (7)

• Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52 [Срок оценки: At Week 52]
• Number of Participants with Endoscopic Remission at Week 52 [Срок оценки: At Week 52]
• Number of Participants with Clinical Remission at Week 52 [Срок оценки: At Week 52]
• Number of Participants with Steroid-Free Clinical Remission at Week 52 [Срок оценки: At Week 52]
• Number of Participants with Abnormalities in Laboratory Parameters [Срок оценки: Up to Week 148]
• Number of Participants With Change From Baseline in Laboratory Abnormalities [Срок оценки: Up to week 148]
• Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention [Срок оценки: Up to Week 165]

Критерии участия

Критерии включения

• Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
• Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (<=) 450
• Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:

• a minimum score of 1 for the component of "size of ulcers" AND
• a minimum score of 1 for the component of "ulcerated surface"
• In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
• Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

Критерии исключения

• Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
• Currently has or is suspected to have an abscess
• Has an active fistula during screening or at Week 0 with an anticipated need for surgery
• Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
• Currently has a malignancy or has a history of malignancy within 5 years before screening

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 · 31 центр

• Digestive Health Specialists of the Southeast — Dothan
• East View Medical Research — Mobile
• Clinnova Research — Anaheim
• United Gastroenterologists — Los Alamitos
• TLC Clinical Research Inc — Los Angeles
• Hoag Memorial Hospital — Newport Beach
• Medical Associates Research Group, Inc. — San Diego
• Peak Gastroenterology Associates — Colorado Springs
• … и ещё 23 центра

Франция · 11 центров

• CHU Amiens Picardie — Amiens
• Clermont Ferrand University Hospital — Clermont-Ferrand
• Institut Prive MICI Clinique des Cedres — Échirolles
• Aphm - Hopital Nord — Marseille
• CHU Nantes - Hotel Dieu — Nantes
• Clinique Ambroise Pare — Neuilly-sur-Seine
• CHU Nimes — Nîmes
• Aphp Hopital Saint Antoine — Paris
• … и ещё 3 центра

Германия · 9 центров

• GASTRO-Studien — Berlin
• … и ещё 8 центров

Великобритания · 9 центров

Список центров уточняется — проверьте первичный протокол.

Дания · 8 центров

• Aarhus University Hospital — Aarhus C
• Sydvestjysk Sygehus — Esbjerg
• NAU New Aalborg University Hospital — Gistrup
• Herlev Hospital — Herlev
• Nordsjaellands Hospital, Hillerod — Hilleroed
• Hvidovre Hospital — Hvidovre
• Bispebjerg Hospital — København NV
• Odense UH og Svendberg sygehus — Odense C

Венгрия · 8 центров

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Польша · 8 центров

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Испания · 8 центров

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Канада · 7 центров

• GIRI Gastrointestinal Research Institute — Vancouver
• Charlton Digestive Disease Centre — Hamilton
• London Digestive Disease Institute — London
• Taunton Surgical Centre — Oshawa
• Toronto Immune and Digestive Health Institute Inc — Toronto
• Centre Hospitalier de l'Universite de Montreal — Montreal
• Clinique IMD — Montreal

Италия · 7 центров

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Словакия · 7 центров

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Австрия · 6 центров

• LKH-Univ. Klinikum Graz — Graz
• Medizinische Universitatsklinik Innsbruck — Innsbruck
• LKH - Universitätsklinikum der PMU Salzburg — Salzburg
• Krankenhaus der Barmherzigen Brüder — Vienna
• Klinikum Wels Grieskirchen — Wels
• Universitatsklinikum Wiener Neustadt — Wiener Neustadt

Бельгия · 6 центров

• Cliniques Universitaires Saint Luc — Brussels
• Ziekenhuis Oost-Limburg — Genk
• Ghent University Hospital — Ghent
• Universitair Ziekenhuis Leuven — Leuven
• CHU de Liege — Liège
• Algemeen Ziekenhuis Delta — Roeselare

Чехия · 6 центров

• Vojenska nemocnice Brno — Brno
• Gastroenterologie, s.r.o., Hradec Kralove — Hradec Kralova
• Hepato-gastroenterologie HK, s.r.o. — Hradec Králové
• Fakultni Nemocnice Ostrava — Ostrava-Poruba
• Fakultni nemocnice Kralovske Vinohrady — Prague
• Fakultni Thomayerova nemocnice — Prague

Швеция · 6 центров

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Китай · 4 центра

• Changzhou No 2 Peoples Hospital — Changzhou
• The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The Sixth Affiliated Hospital Sun Yat sen University — Гуанчжоу
• Zhongda Hospital Southeast University — Нанкин

Нидерланды · 3 центра

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Идентификаторы

NCT: NCT07499232 · CNTO1959CRD3009 · CNTO1959CRD3009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗