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A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Trial ID: NCT03568318
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
- Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline Visit and subject meets Hanifin and Rajka criteria.
- Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index
(EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, ≥ 10% of body
surface area (BSA) with AD involvement, and weekly average of daily Worst Pruritus
numerical rating scale (NRS) ≥ 4.
- Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days
before the Baseline Visit.
- Documented history of inadequate response to topical corticosteroids or topical
calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to
- 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
drug: Topical corticosteroids (TCS)
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