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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2023

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis; Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms ADACCESS
  • Sponsors HEXAL; Novartis; Sandoz
  • Most Recent Events

    • 30 Jan 2023 According to Sandoz media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for a citrate-free high concentration formulation of adalimumab. The authorization includes all indications covered by the reference medicine: rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis and uvetis.
    • 09 Nov 2021 Results of a pooled analysis of data from 4 phase I studies (study 101,102, 103 & 104) and 2 phase III studies (ADACCESS & ADMYRA) presented at the ACR Convergence 2021
    • 05 Jun 2021 Results of a pooled analysis of data from 4 phase I studies (study 101,102, 103 & 104) and 2 phase III studies (ADACCESS & ADMYRA) assessing the local tolerance to formulations containing citrate bufferpresented at the 22nd Annual Congress of the European League Against Rheumatism
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