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Recruiting
Trial ID: NCT03569293
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis
Clinical Associate Professor, Dermatology
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
drug: Upadacitinib
drug: Placebo for Upadacitinib
Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305