BENITIONSClinical Trial Intelligence

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

3상 진행 중(모집 완료) NCT03451851

대상 질환Psoriasis
임상 단계3상
스폰서Janssen Research & Development, LLC
상태진행 중(모집 완료)
참여자 수120 명
중재(약물)Guselkumab, Placebo for guselkumab, Etanercept
시작일2018년 7월 11일
완료일2023년 7월 19일
결과 공개일2025년 3월 28일

요약

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
Group 2 (Part 1): Guselkumab (Week 0-16)65.9 Percentages of participants
Group 3 (Part 1): Etanercept (Week 0-16)69.2 Percentages of participants
p-value<0.001
Difference in percentage49.9 (95% CI 25.9–69.4)

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
Group 2 (Part 1): Guselkumab (Week 0-16)75.6 Percentage of Participants
Group 3 (Part 1): Etanercept (Week 0-16)69.2 Percentage of Participants
p-value<0.001
Difference in percentage55.6 (95% CI 32.1–74.0)

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