This phase 2b, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study was conducted between April 15, 2016, and April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States (NCT02780167 ) (trial protocol in Supplement 2 ). A 35-day screening period was followed by a 12-week double-blinded, placebo-controlled treatment period and a 4-week follow-up (eFigure 2 in Supplement 1 ). The study was conducted in compliance with the Declaration of Helsinki15 (link) and all International Council for Harmonization Good Clinical Practice Guidelines. All local regulatory requirements were followed. This research was approved by institutional review boards or ethics committees at each study site (eTable 1 in Supplement 1 ). All patients provided written informed consent.
Eligible patients were men or women aged 18 to 75 years with a clinical diagnosis of moderate to severe AD (percentage of affected body surface area [%BSA] ≥10; Investigator’s Global Assessment [IGA] score ≥3; and Eczema Area and Severity Index [EASI] score ≥12) for 1 year or more before day 1 of the study and inadequate response to topical medications (topical corticosteroids or topical calcineurin inhibitors) for 4 weeks or more (based on investigator’s judgment) or inability to receive topical treatment within 12 months before the first dose of study drug because it was medically inadvisable (eg, application to a large %BSA, which is associated with increased risk for systemic absorption and suppression of the hypothalamic-pituitary-adrenal axis, and cutaneous adverse effects such as burning or stinging sensations with topical calcineurin inhibitors or skin atrophy, purpura, telangiectasia, and striae with chronic use of topical corticosteroids). Patients who had used topical corticosteroids or topical calcineurin inhibitors within 1 week of the first dose of study drug were excluded (see eAppendix inSupplement 1 for detailed eligibility criteria). Patients were permitted to use oral antihistamines and nonmedicated emollient (CeraVe lotion [CeraVe]; or Aquaphor [Beiersdorf Inc]) and sunscreen (both provided by the sponsor) during the study. Patients who received prohibited systemic or topical medication for AD before week 12 were discontinued from treatment.
Eligible patients were men or women aged 18 to 75 years with a clinical diagnosis of moderate to severe AD (percentage of affected body surface area [%BSA] ≥10; Investigator’s Global Assessment [IGA] score ≥3; and Eczema Area and Severity Index [EASI] score ≥12) for 1 year or more before day 1 of the study and inadequate response to topical medications (topical corticosteroids or topical calcineurin inhibitors) for 4 weeks or more (based on investigator’s judgment) or inability to receive topical treatment within 12 months before the first dose of study drug because it was medically inadvisable (eg, application to a large %BSA, which is associated with increased risk for systemic absorption and suppression of the hypothalamic-pituitary-adrenal axis, and cutaneous adverse effects such as burning or stinging sensations with topical calcineurin inhibitors or skin atrophy, purpura, telangiectasia, and striae with chronic use of topical corticosteroids). Patients who had used topical corticosteroids or topical calcineurin inhibitors within 1 week of the first dose of study drug were excluded (see eAppendix in
