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
Phase of Trial: Phase III
Latest Information Update: 01 Jun 2017
At a glance
- Drugs Adalimumab (Primary)
- Indications Plaque psoriasis
- Focus Registrational; Therapeutic Use
- Acronyms ADACCESS
- Sponsors HEXAL; Novartis; Sandoz
- 31 May 2017 According to a Sandoz media release, the European Medicines Agency (EMA) has accepted for regulatory review the Marketing Authorization Application (MAA) for adalimumab biosimilar (Humira). The submission included data from this trial and from other pharmacokinetic studies.
- 06 Mar 2017 According to a Sandoz media release, results from this study were presented at the American Academy of Dermatology (AAD).
- 06 Mar 2017 Results published in a Sandoz media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History