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

Launched by SANDOZ · Jun 28, 2013

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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