A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis

M16-046

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

2019-02-21

2020-08-27

2020-12-09

Completed

Early phase I

673

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 673, 'type': 'ACTUAL'}}

2024-03-15