A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
Inclusion criteria:
Men or women ≥ 18 and ≤ 75 years of age at time of screening
Stable moderate to severe plaque psoriasis for at least 6 months before baseline
Moderate to severe psoriasis defined at screening and baseline by:
Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
No known history of active tuberculosis
Subject is a candidate for systemic therapy or phototherapy procedures
Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Exclusion Criteria:
Other Inclusion/Exclusion criteria may apply