A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT04397263
Last Updated: 2025-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2020-06-10
2025-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Guselkumab
Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Interventions
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Guselkumab
Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Unstable doses of concomitant Crohn's disease therapy
* Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
* Prior exposure to p40 inhibitors or p19 inhibitors
* Any medical contraindications preventing study participation
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K., Japan Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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KOKIKAI Tokatsu Tsujinaka Hospital
Abiko, , Japan
Institute of Science Tokyo Hospital
Bunkyō City, , Japan
Hitachi General Hospital
Hitachi, , Japan
Asahikawa Medical University Hospital
Hokkaido, , Japan
Ofuna Chuo Hospital
Kamakura, , Japan
Kishiwada Tokushukai Hospital
Kishiwada, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Kyorin University Hospital
Mitaka, , Japan
Kenseikai Dongo Hospital
Nara, , Japan
Hyogo Medical University Hospital
Nishinomiya Shi, , Japan
Okayama University Hospital
Okayama, , Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, , Japan
Saga University Hospital
Saga, , Japan
Kitasato University Hospital
Sagamihara, , Japan
Saitama Medical Center
Saitama, , Japan
Sapporo Tokushukai Hospital
Sapporo, , Japan
Sendai Kosei Hospital
Sendai Miyagi, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
National Center for Global Health and Medicine
Shinjuku, , Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, , Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
National Hospital Organization Toyohashi Medical Center
Toyohashi, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CNTO1959CRD3003
Identifier Type: OTHER
Identifier Source: secondary_id
CR108801
Identifier Type: -
Identifier Source: org_study_id
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