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.

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

Stanford Investigator(s)

Albert Sean Chiou, MD, MBA
Albert Sean Chiou, MD, MBA

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

      - 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

      - 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

   - 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: Upadacitinib

drug: Placebo for Upadacitinib


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305