A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Официальное название

A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Обзор

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Вмешательства

• Препарат JNJ-78934804
  JNJ-78934804 will be administered subcutaneously.
• Препарат Guselkumab
  Guselkumab will be administered subcutaneously.

Первичные конечные точки

• Co-Primary: Percentage of Participants with Clinical Remission at Week 48 [Срок оценки: At Week 48]
• Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48 [Срок оценки: At Week 48]

Вторичные конечные точки (10)

• Percentage of Participants with Deep Remission at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Corticosteroid-Free (90-Day) Clinical Remission at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Sustained Clinical Remission [Срок оценки: At Weeks 12 and 48]
• Percentage of Participants with Histologic-Endoscopic Remission at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Clinical Remission at Week 12 [Срок оценки: At Week 12]
• Percentage of Participants with Endoscopic Response at Week 12 [Срок оценки: At Week 12]
• Number of Participants with Adverse Events (AE) and Serious AEs (SAEs) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
• Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
• Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
• Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies

Критерии исключения

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
• Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
• Presence of draining (that is, functioning) stoma or ostomy
• Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
• Currently has or is suspected of having an abscess

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Япония · 13 центров

• National Hospital Organization Hirosaki National Hospital — Hirosaki
• Kagoshima IBD Gastroenterology Clinic — Kagoshima
• Tsujinaka Hospital Kashiwanoha — Kashiwa
• Kobe University Hospital — Kobe
• Kumamoto University Hospital — Kumamoto
• Japanese Red Cross Kumamoto Hospital — Kumamoto
• Takano Hospital — Kumamoto
• Kitasato University Kitasato Institute Hospital — Minatoku
• … и ещё 5 центров

США · 12 центров

• Clinnova Research — Anaheim
• Gastro SB Clinic — Chula Vista
• Medical Associates Research Group, Inc. — San Diego
• Peak Gastroenterology Associates — Colorado Springs
• Sanchez Clinical Research, Inc — Miami
• GCP Clinical Research — Tampa
• Atlanta Gastroenterology Specialists — Suwanee
• Tri-State Gastroenterology Assoc — Crestview Hills
• … и ещё 4 центра

Израиль · 10 центров

• Assuta Medical center — Ashdod
• Bnai Zion Medical Center — Haifa
• Rambam Medical Center — Haifa
• Wolfson Medical Center — Holon
• Shaare Zedek Medical Center — Jerusalem
• Meir Medical Center — Kfar Saba
• Galilee Medical Center — Nahariya
• Rabin Medical Center — Petah Tikva
• … и ещё 2 центра

Канада · 6 центров

• GI Research Institute (G.I.R.I.) — Vancouver
• Viable Clinical Research — Kentville
• London Digestive Disease Institute — London
• West GTA Research Inc — Mississauga
• Toronto Immune and Digestive Health Institute Inc — Toronto
• CHUM - Centre hospitalier universitaire de Montreal — Montreal

Turkey (Türkiye) · 6 центров

• Antalya Training And Research Hospital — Antalya
• Bezmialem University Medical Faculty — Istanbul
• Marmara University Pendik Training Hospital — Istanbul
• Izmir Sehir Hastanesi — Izmir
• Kocaeli University Medical Faculty — Kocaeli
• Mersin University Medical Faculty — Mersin

Австралия · 3 центра

• Banksia Trials SA — Adelaide
• IBD SA — Kurralta Park
• Mater Misericordiae Hospital — South Brisbane

Малайзия · 3 центра

• Sultan Idris Shah Hospital — Kajang
• Hospital Queen Elizabeth — Kota Kinabalu
• Hospital Sultanah Nur Zahirah — Kuala

Бразилия · 1 центр

• BR Trials — São Paulo

Тайвань · 1 центр

• Linkou Chang Gung Memorial Hospital — Taoyuan

Идентификаторы

NCT: NCT07577843 · 78934804CRD3001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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