Heads Up
Brief summary
This is a phase 3, randomized, multi-center study that will evaluate an active drug 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.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 76 Years.
Inclusion Criteria:
- Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema
Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10%
body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and
Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- 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.