A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Phase 3
Active, not recruiting
NCT05197049
| Condition | Crohn Disease |
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| Phase | Phase 3 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Active, not recruiting |
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| Enrollment | 350 participants |
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| Interventions | Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3 |
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| Start date | Jan 19, 2022 |
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| Completion date | Jul 4, 2023 |
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| Results posted | Feb 21, 2025 |
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Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Percentage of Participants Who Achieved Clinical Remission at Week 12
At Week 12 · Percentage of participants
| Placebo | 21.4 Percentage of participants |
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| Combined: Guselkumab 400 mg | 56.1 Percentage of participants |
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| p-value | < 0.001 |
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| Adjusted treatment difference:percentage | 34.9 (95% CI 25.1–44.6) |
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Percentage of Participants Who Achieved Endoscopic Response at Week 12
At Week 12 · Percentage of participants
| Placebo | 21.4 Percentage of participants |
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| Combined: Guselkumab 400 mg | 41.3 Percentage of participants |
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| p-value | < 0.001 |
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| Adjusted treatment difference:percentage | 19.9 (95% CI 10.2–29.6) |
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Open in BENITIONS
View on ClinicalTrials.gov
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