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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
Clinical Professor, Dermatology
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