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
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
This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults 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 double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks.
Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90025-7014, United States
Chicago, Illinois 60611-2927, United States
Sugar Land, Texas 77479-3153, United States
Zagreb, City of Zagreb 10000, Croatia
Ivanić-Grad, Zagreb County 10310, Croatia
Blankenfeld-mahlow, 15831, Germany
Budapest XIII, 1135, Hungary
Kuala Lumpur, Selangor 56000, Malaysia
Wellington, 6021, New Zealand
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-094, Poland
Taipei City, Taipei 100, Taiwan
Zaporizhzhya, Zaporizhzhia Oblast 69063, Ukraine