At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 465 enrolled
Drug / intervention
GP2017 Adalimumab +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 Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
In Brief
A Phase 3 clinical trial evaluating GP2017 Adalimumab and Humira ® Adalimumab for Plaque Type Psoriasis. Completed, enrolled 465 participants across 79 sites in 4 countries.
Detailed Summary
The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Type Psoriasis
CountriesBulgaria, France, Slovakia, United States
CollaboratorsHexal AG
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionJul 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedDec 19, 2013
Enrollment StartDec 1, 2013
Primary CompletionJul 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.5 years ago
Interventions
GP2017 Adalimumabdrug
Humira ® Adalimumabdrug