Conditions: Chronic Stable Plaque Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 531
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter arm 2: Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter

Interventions: intervention 1: GP2015 Etanercept intervention 2: Enbrel
Intervention descriptions: intervention 1: Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. intervention 2: Enbrel is used as reference product to GP2015.

Protocol document: