A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2020-12-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal; Upadacitinib

Criteria

Inclusion Criteria:

• Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.

• Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

Exclusion Criteria:

• Participant has prior exposure to Janus Kinase (JAK) inhibitor.

• Participant has prior exposure to dupilumab.

• Participant is unable or unwilling to discontinue current AD treatments prior to the study.

• Participant has requirement of prohibited medications during the study.

• Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.

• Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.