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VOLTAIRE-X: Pharmacokinetics, Safety, Immunogenicity and Efficacy of BI 695501 Versus Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis: a Randomized, Double-blind, Parallel-arm, Multiple-dose, Active Comparator Trial

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Trial Profile

VOLTAIRE-X: Pharmacokinetics, Safety, Immunogenicity and Efficacy of BI 695501 Versus Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis: a Randomized, Double-blind, Parallel-arm, Multiple-dose, Active Comparator Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jan 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Pharmacokinetics; Registrational
  • Acronyms VOLTAIRE-X
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 15 Nov 2023 Results of pooled subgroup analysis from five phase 3 randomized controlled clinical trials (VOLTAIRE-RA , VOLTAIRE-RAext, VOLTAIRE-CD, VOLTAIRE-PsO and VOLTAIRE-X) assessing incidence of safety endpoints in patients with RA )presented at the ACR Convergence 2023
    • 24 Oct 2023 Results published in the Dermatology and Therapy.
    • 01 Jul 2023 According to a Boehringer Ingelheim media release, the company announced today that Cyltezo (adalimumab-adbm), a U.S. Food and Drug Administration (FDA)-approved Interchangeable biosimilar to Humira (adalimumab), is now commercially available in the U.S. Cyltezo was initially approved as a biosimilar in 2017 for use in multiple chronic inflammatory diseases.
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