A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus

Trial Profile

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 31 Oct 2017

At a glance

  • Drugs Interferon alpha kinoid (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Sponsors Neovacs
  • Most Recent Events

    • 27 Jul 2017 The trial has been completed in Spain (European Clinical Trials Database; EudraCT2015-001341-86 ).
    • 11 Jul 2017 According to a Neovacs media release, the company has received a positive data review by the Independent Data and Safety Monitoring Board (IDSMB) for this trial. The board reviewed the cumulative data, and informed the company that it has identified no safety concerns, and recommended the continuation of the study without any modifications.
    • 20 Jun 2017 According to a Neovacs media release, results from the study are expected in the second quarter of 2018. In order to ensure the validity of the clinical results of this study, Neovacs is taking advice from three expert committees, the independent Data Safety Monitoring Board (iDSMB), an independent "Adjudication Committee" and internal "Steering Committee".
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