A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Recruiting

Trial ID: NCT03568318

Purpose

The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) 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 Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Stanford Investigator(s)

Justin M Ko, MD, MBA
Justin M Ko, MD, MBA

Clinical Professor, Dermatology

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

Clinical Associate Professor, Dermatology

Eligibility


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

Intervention(s):

drug: Upadacitinib

drug: Topical corticosteroids (TCS)

drug: Placebo

Recruiting

Contact Information

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