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

• Status: Active, not recruiting
• Trial end date: 2022-08-12
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan 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:

• 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.

• Able to tolerate topical corticosteroids for atopic dermatitis lesions.

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.

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