A Phase 3 Evaluating Upadacitinib with Topical Corticosteroids in Severe Atopic Dermatitis

UCI Specialty Area: Dermatology

Principal Investigator: Natasha Mesinkovska

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

A Study On:

Atopic Dermatitis

Study Description

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.

Eligibility

Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age

Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit

Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus

Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis

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

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

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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