Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Trial ID or NCT#
NCT03569293
Status
RECRUITING
Purpose
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.
Official Title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Eligibility Criteria
Ages Eligible for Study: 12 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years of age - 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 Visits; - Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits; - ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits; - 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
Exclusion Criteria:
- - Prior exposure to any Janus kinase (JAK) inhibitor - Unable or unwilling to discontinue current atopic dermatitis 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
Investigator(s)
View on ClinicalTrials.gov
