Official Title

M16-047: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids on Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Purpose

The purpose of this study is to compare the effectiveness and safety of Upadacitinib (ABT-494) to placebo (pill without any active substance that looks like upadacitinib) in combination with topical corticosteroids for adolescents (12-17 years of age) and adults (18-75 years of age with moderate to severe atopic dermatitis (AD).

Could this study be right for you?

- Adolescent subjects must weigh more than 40 kg (88 lb) - Subject must be in good general health (other than Atopic Dermatitis) - Subject must have chronic Atopic Dermatitis (AD) with onset of symptoms at least 3 years before first dose of study medication - Subject must have documented history of inadequate response to topical corticosteroids (TCS), topical calcineurin inhibitor (TCI), or systemic treatment for AD within 6 months prior to first dose of study medication - Female subjects must not be pregnant, breastfeeding, or considering becoming pregnant for the duration of the study and for 30 days after last dose of the study drug. - No history of drug or alcohol abuse in the 6 months prior to receiving the first dose of study medication

Age Range

12 and up