drugset / Trial / NCT01891864

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

NCT01891864

Phase 3 Completed 531 enrolled Sandoz Hexal AG · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-06
Primary completion
2014-06
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous

Indications