A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Trial ID or NCT#
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 AD who are candidates for systemic therapy.
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
- - Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age
- - Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline
- - Active moderate to severe AD defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
- - Candidate for systemic therapy or have recently required systemic therapy for AD
- - Documented history (within 6 months prior to Baseline) of inadequate response to topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD or for whom topical treatments are otherwise medically inadvisable due to side effects or safety risks
- - Prior exposure to any Janus kinase (JAK) inhibitor
- - Unable or unwilling to discontinue current AD treatments prior to the study
- - Requirement of prohibited medications during the study
- - Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- - Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
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