A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
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.
- Atopic Dermatitis
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Participants administered with upadacitinib
|Participants are administered with upadacitinib from baseline to week 24 and placebo pre-filled syringe at baseline visit (2 injections) followed by an injection every other week until week 22||
Participants administered with dupilumab
|Participants are administered with dupilumab (2 injections) at baseline followed by one every other week until week 22 and placebo tablets daily from baseline to week 24||
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