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

Trial ID or NCT#

NCT03568318

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 12 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Justin M Ko, MD, MBA
Justin M Ko, MD, MBA
Dermatologist, Melanoma specialist, Cutaneous oncology specialist, Hair loss specialist, Psoriasis specialist
Clinical Professor, Dermatology
Albert Sean Chiou, MD, MBA
Albert Sean Chiou, MD, MBA
Dermatologist, Cutaneous oncology specialist
Clinical Associate Professor, Dermatology