At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 531 enrolled
Drug / intervention
GP2015 Etanercept +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GP2015 Etanercept and Enbrel for Chronic Stable Plaque Psoriasis. Completed, enrolled 531 participants across 74 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Stable Plaque Psoriasis
CountriesBulgaria, Czechia, Estonia, Germany, Hungary, Poland, Romania, Russia, Slovakia, South Africa, Ukraine, United Kingdom
CollaboratorsHexal AG
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJul 2013
Primary CompletionJun 2014
Study CompletionMar 2015
TodayJul 2026
First PostedJul 3, 2013
Enrollment StartJun 1, 2013
Primary CompletionJun 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.0 years ago
Interventions
GP2015 Etanerceptdrug
Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.
Enbreldrug
Enbrel is used as reference product to GP2015.