Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Etanercept (GP2015) and Enbrel® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12.

The purpose of this confirmatory safety and efficacy study (GP15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of GP2015 and Enbrel (EU-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel on efficacy, overall safety, and immunogenicity. Since only EU-authorized Enbrel was utilized in this study, the use of the term "Enbrel" throughout this report describes EU-authorized Enbrel only.

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 baseline

• Moderate to severe psoriasis as defined at baseline by:

  • PASI score of 10 or greater and,
  • Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
  • Body Surface Area affected by plaque-type psoriasis of 10% or greater

• 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:

• Forms of psoriasis other than chronic plaque-type
• Drug-induced psoriasis
• Ongoing use of prohibited treatments
• Previous exposure to etanercept
• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept

Other In-/Exclusion criteria may apply