BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT03569293

ConditionAtopic Dermatitis
PhasePhase 3
SponsorAbbVie
StatusCompleted
Enrollment912 participants
InterventionsPlacebo for Upadacitinib, Upadacitinib
Start dateAug 13, 2018
Completion dateJan 6, 2021
Results postedFeb 3, 2022

Summary

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)

Open in BENITIONS View on ClinicalTrials.gov

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