A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.
The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.
Inclusion Criteria:
Men or women at least 18 years of age at time of screening
Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
Moderate to severe psoriasis as defined at baseline by:
Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
Exclusion Criteria:
Other In-/Exclusion criteria may apply
Kosice-Saca, Slovakia