A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
3期
进行中（已停止招募）
NCT03451851
| 适应症 | Psoriasis |
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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 | 120 人 |
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| 干预（药物） | Guselkumab, Placebo for guselkumab, Etanercept |
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| 开始日期 | 2018年7月11日 |
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| 完成日期 | 2023年7月19日 |
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| 结果公布日 | 2025年3月28日 |
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摘要
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
At Week 16 · Percentages of participants
| Group 1 (Part 1): Placebo (Week 0-16) | 16.0 Percentages of participants |
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| Group 2 (Part 1): Guselkumab (Week 0-16) | 65.9 Percentages of participants |
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| Group 3 (Part 1): Etanercept (Week 0-16) | 69.2 Percentages of participants |
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| p-value | <0.001 |
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| Difference in percentage | 49.9 (95% CI 25.9–69.4) |
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Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
At Week 16 · Percentage of Participants
| Group 1 (Part 1): Placebo (Week 0-16) | 20.0 Percentage of Participants |
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| Group 2 (Part 1): Guselkumab (Week 0-16) | 75.6 Percentage of Participants |
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| Group 3 (Part 1): Etanercept (Week 0-16) | 69.2 Percentage of Participants |
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| p-value | <0.001 |
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| Difference in percentage | 55.6 (95% CI 32.1–74.0) |
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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。