Latest1 information on COVID-19
©2022 Stanford Medicine
Recruiting
Trial ID: NCT03568318
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
Clinical Professor, Dermatology
Clinical Associate Professor, Dermatology
Inclusion Criteria:
- 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
Baseline Visit
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current atopic dermatitis (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
drug: Upadacitinib
drug: Topical corticosteroids (TCS)
drug: Placebo
Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305