A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Who is this study for? Adult patients with Crohn's Disease
What treatments are being studied? Guselkumab
Status: Completed
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
• Have screening laboratory test results within the protocol specified parameters
• A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Locations
Other Locations
Japan
KOKIKAI Tokatsu Tsujinaka Hospital
Abiko
Institute of Science Tokyo Hospital
Bunkyō City
Hitachi General Hospital
Hitachi
Asahikawa Medical University Hospital
Hokkaido
Ofuna Chuo Hospital
Kamakura
Kishiwada Tokushukai Hospital
Kishiwada
Japanese Red Cross Kumamoto Hospital
Kumamoto
Kumamoto University Hospital
Kumamoto
Kyorin University Hospital
Mitaka
Kenseikai Dongo Hospital
Nara
Hyogo Medical University Hospital
Nishinomiya Shi
Ishida Clinic of IBD and Gastroenterology
Ōita
Okayama University Hospital
Okayama
Saga University Hospital
Saga
Kitasato University Hospital
Sagamihara
Saitama Medical Center
Saitama
Sapporo Tokushukai Hospital
Sapporo
Sendai Kosei Hospital
Sendai Miyagi
Jichi Medical University Hospital
Shimotsuke
National Center for Global Health and Medicine
Shinjuku
Tokyo Women's Medical University Hospital
Shinjuku-ku
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku
Osaka Medical and Pharmaceutical University Hospital
Takatsuki
Toyama Prefectural Central Hospital
Toyama
National Hospital Organization Toyohashi Medical Center
Toyohashi
Time Frame
Start Date:2020-06-10
Completion Date:2025-09-12
Participants
Target number of participants:38
Treatments
Experimental: Guselkumab
Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.