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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Sponsor: Janssen Research & Development, LLC
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2026-05-22
Completion Date
2030-07-12
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Guselkumab
Guselkumab will be administered subcutaneously.
Locations (55)
Clinnova Research
Anaheim, California, United States
Gastro SB Clinic
Chula Vista, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Atlanta Gastroenterology Specialists
Suwanee, Georgia, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
New York Gastroenterology Associates
New York, New York, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Banksia Trials SA
Adelaide, Australia
IBD SA
Kurralta Park, Australia
Mater Misericordiae Hospital
South Brisbane, Australia
BR Trials
São Paulo, Brazil
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
Viable Clinical Research
Kentville, Nova Scotia, Canada
London Digestive Disease Institute
London, Ontario, Canada
West GTA Research Inc
Mississauga, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada
Assuta Medical center
Ashdod, Israel
Bnai Zion Medical Center
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Galilee Medical Center
Nahariya, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
National Hospital Organization Hirosaki National Hospital
Hirosaki, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Japan
Kobe University Hospital
Kobe, Japan
Kumamoto University Hospital
Kumamoto, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Japan
Takano Hospital
Kumamoto, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Japanese Red Cross Osaka Hospital
Osaka, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Japan
National Hospital Organization Shizuoka Medical Center
Shimizu, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, Japan
Sultan Idris Shah Hospital
Kajang, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Malaysia
Hospital Sultanah Nur Zahirah
Kuala, Malaysia
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Antalya Training And Research Hospital
Antalya, Turkey (Türkiye)
Bezmialem University Medical Faculty
Istanbul, Turkey (Türkiye)
Marmara University Pendik Training Hospital
Istanbul, Turkey (Türkiye)
Izmir Sehir Hastanesi
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, Turkey (Türkiye)