A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Официальное название

A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Вмешательства

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

Первичные конечные точки

• Percentage of Participants in Clinical Remission at Week 48 [Срок оценки: At Week 48]

Вторичные конечные точки (12)

• Percentage of Participants with Endoscopic Improvement 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 Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0 [Срок оценки: At Weeks 12, 24, and 48]
• Percentage of Participants in Abdominal Pain 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 PROMIS-29 Mental Component Summary (MCS) Response at Week 48 [Срок оценки: At Week 48]
• Percentage of Participants in Clinical Remission at Week 12 [Срок оценки: At Week 12]
• Percentage of Participants with Endoscopic Improvement at Week 12 [Срок оценки: At Week 12]
• Percentage of Participants with Mayo SF/RB Response at Week 2 [Срок оценки: At Week 2]
• Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
• Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
• An endoscopy subscore >=2 as obtained during central review of the screening video endoscopy
• Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies

Критерии исключения

• Isolated proctitis (UC limited to the rectum only or to less than \[<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
• Has a history of or ongoing chronic or recurrent infectious disease
• Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
• Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

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 · 14 центров

• Matsuda Hospital — Hamamatsu
• National Hospital Organization Mito Medical Center — Higashi-Ibaraki
• Kagoshima IBD Gastroenterology Clinic — Kagoshima
• Tsujinaka Hospital Kashiwanoha — Kashiwa
• Kumamoto University Hospital — Kumamoto
• Takano Hospital — Kumamoto
• Kitasato University Kitasato Institute Hospital — Minatoku
• National Hospital Organization Osaka National Hospital — Osaka
• … и ещё 6 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
• Tri-State Gastroenterology Assoc — Crestview Hills
• Michigan Center of Medical Research — Farmington Hills
• … и ещё 4 центра

Израиль · 10 центров

• Assuta Medical center — Ashdod
• Rambam Medical Center — Haifa
• Bnai Zion 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 · 8 центров

• South Edmonton Gastroenterology Research Clinic — Edmonton
• GI Research Institute (G.I.R.I.) — Vancouver
• Viable Clinical Research — Kentville
• Barrie GI Associates — Barrie
• Charlton Digestive Disease Centre — Hamilton
• London Digestive Disease Institute — London
• Toronto Immune and Digestive Health Institute Inc — Toronto
• CHUM - Centre hospitalier universitaire de Montreal — Montreal

Turkey (Türkiye) · 7 центров

• Antalya Training And Research Hospital — Antalya
• Sanko Universitesi Hastanesi — Gaziantep
• Bezmialem University Medical Faculty — Istanbul
• Istanbul University Cerrahpasa Medical Faculty — Istanbul
• Izmir Sehir Hastanesi — Izmir
• Kocaeli University Medical Faculty — Kocaeli
• Mersin University Medical Faculty — Mersin

Малайзия · 4 центра

• Hospital Ampang — Ampang
• Sultan Idris Shah Hospital — Kajang
• Hospital Kuala Lumpur — Kuala Lumpur
• Hospital Sultanah Nur Zahirah — Kuala Terengganu

Австралия · 3 центра

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

Бразилия · 2 центра

• Pesquisare Saude — Santo André
• BR Trials — São Paulo

Китай · 1 центр

• The First Affiliated Hospital Sun Yat sen University — Гуанчжоу

South Korea · 1 центр

• Samsung Medical Center — Gangnam Gu

Тайвань · 1 центр

• Linkou Chang Gung Memorial Hospital — Taoyuan

Идентификаторы

NCT: NCT07577856 · 78934804UCO3001 · 2026-525923-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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