Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

• Status: Active, not recruiting
• Trial end date: 2025-10-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Upadacitinib

Criteria

Inclusion Criteria:

• 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 before Baseline Visit

• Active moderate to severe AD 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 AD

• 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 (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