A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Фаза 3
Идёт, набор закрыт
NCT03451851
| Заболевание | Psoriasis |
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| Фаза | Фаза 3 |
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| Спонсор | Janssen Research & Development, LLC |
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| Статус | Идёт, набор закрыт |
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| Участники | 120 участн. |
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| Вмешательство | Guselkumab, Placebo for guselkumab, Etanercept |
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| Дата начала | 11.07.2018 |
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| Дата завершения | 19.07.2023 |
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| Публикация результатов | 28.03.2025 |
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Кратко
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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