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Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Trial ID: NCT03569293
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 atopic dermatitis (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 ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline
Visit and subject meets Hanifin and Rajka criteria.
- Active moderate to severe AD defined by:
- Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline
- Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and
- ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- Candidate for systemic therapy or have recently required systemic therapy for AD
- 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 (TCS) or topical
calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months
before Baseline Visit
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis treatments prior to the
- 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: Placebo for Upadacitinib
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