Atopic Dermatitis Clinical Trial
Official title:
A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis
The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).
The study was to include a 16-week double-blind treatment period (Period 1) and a 72-week
double-blind treatment period (Period 2) for a total of 88 weeks of treatment. Participants
who met eligibility criteria were to be randomized in a 1:1:1:1 ratio to one of the four
treatment groups. Participants who completed Period 1 were re-randomized at Week 16 into a
72-week double-blind, placebo-controlled treatment period (Period 2) in a 1:1 ratio:
- Group 1: Upadacitinib 7.5 mg once daily (QD) (Day 1 to Week 16) → upadacitinib 7.5 mg QD
or placebo (Week 16 - and thereafter)
- Group 2: Upadacitinib 15 mg QD (Day 1 to Week 16) → upadacitinib 15 mg QD or placebo
(Week 16 and thereafter)
- Group 3: Upadacitinib 30 mg QD (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo
(Week 16 - and thereafter)
- Group 4: Matching placebo (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo (Week 16
and thereafter)
In Period 1, discontinuation from study drug was mandatory for any participant with an Eczema
Area and Severity Index (EASI) score worsening of 25% or more compared with their Baseline
EASI score at any 2 consecutive scheduled study visits from Week 4 to Week 12.
In Period 2, blinded rescue therapy with upadacitinib 30 mg QD was provided after the first
instance of a < EASI 50 response starting at the Week 20 visit (4 weeks after
re-randomization into Period 2) for the remainder of the study.
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