A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
3期
进行中(已停止招募)
NCT05197049
| 适应症 | Crohn Disease |
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| 分期 | 3期 |
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| 申办方 | Janssen Research & Development, LLC |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 350 人 |
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| 干预(药物) | Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3 |
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| 开始日期 | 2022年1月19日 |
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| 完成日期 | 2023年7月4日 |
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| 结果公布日 | 2025年2月21日 |
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摘要
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 |
| Adjusted treatment difference:percentage | 34.9 (95% CI 25.1–44.6) |
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 |
| Adjusted treatment difference:percentage | 19.9 (95% CI 10.2–29.6) |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。