Efficacy of Gevokizumab in polymyositis/dermatomyositis

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled proof-of-concept study of the efficacy of gevokizumab 60 mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

• IRAS ID

  135286

• Contact name

  Hector Chinoy

• Contact email

  hector.chinoy@manchester.ac.uk

• Eudract number

  2012-005772-34

• Research summary

  This study is looking at the effectiveness and safety of Gevokizumab in patients with Polymyositis or Dermatomyositis. Both are rare inflammatory diseases usually treated with corticosteroids. The study patients must either be intolerant or resistant to corticosteroids OR dependent on corticosteroids and on a stable dose.
  A total of 40 patients of both genders will partake in this study in about 12 countries.
  Gevokizumab is an anti-inflammatory antibody. It regulates a protein (interleukin-1 beta or IL-1-beta) that results in tissue inflammation. IL1-beta has been shown to be involved in the inflammation that causes polymyositis and dermatomyositis. Thus, the study drug could improve symptoms in both diseases. In this study, 60 mg of Gevokizumab will be injected every 4 weeks, over the course of 20 weeks (6 injections in total).
  The efficacy will be evaluated with the clinical improvement on muscle strength and skin symptoms, according to guidelines. The safety evaluation involves the effect of Gevokizumab versus the dummy drug regarding adverse events, vital signs, blood and urine analysis, heart check-up (electrocardiogram). Patients will also be asked to participate in an optional additional part. The purpose of this sub-study is the analysis of genomic biomarkers. It allows us to evaluate various characteristics of the genome (set of all genes) related to the patient’s treatment. This will allow a better understanding of polymyositis and dermatomyositis and the efficacy and safety of the treatment.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/0005

• Date of REC Opinion

  21 Jan 2014

• REC opinion

  Favourable Opinion