BENITIONSClinical Trial Intelligence

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

3상 완료 NCT03569293

대상 질환Atopic Dermatitis
임상 단계3상
스폰서AbbVie
상태완료
참여자 수912 명
중재(약물)Placebo for Upadacitinib, Upadacitinib
시작일2018년 8월 13일
완료일2021년 1월 6일
결과 공개일2022년 2월 3일

요약

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

Baseline and Week 16 · percentage of participants

Placebo16.3 percentage of participants
Upadacitinib 15 mg QD69.6 percentage of participants
Upadacitinib 30 mg QD79.7 percentage of participants
p-value<0.001
Adjusted Response Rate Difference63.4 (95% CI 57.1–69.8)

Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

Baseline and Week 16 · percentage of participants

Placebo8.4 percentage of participants
Upadacitinib 15 mg QD48.1 percentage of participants
Upadacitinib 30 mg QD62.0 percentage of participants
p-value<0.001
Adjusted Response Rate Difference53.6 (95% CI 47.2–60.0)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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