CFZ533 in patients with primary Sjögren's syndrome

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome

• IRAS ID

  153362

• Contact name

  Benjamin Fisher

• Contact email

  b.fisher@bham.ac.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2013-004808-19

• Research summary

  The purpose of this trial is to evaluate whether the study drug CFZ533 is well tolerated and whether it has positive effects on primary Sjögren’s syndrome. The pharmacokinetics of CFZ533 will also be investigated. Pharmacokinetics is the study of the way the body absorbs, distributes and gets rid of a drug. In addition, this study will also examine whether there is any relationship between CFZ533 and some biomarkers which are clinical parameters used to assess the disease activities of primary Sjögren’s syndrome, and the time course of this relationship.
  CFZ533 is a biologic which is an antibody that binds to a protein called CD40 which exists in some blood cells. The binding of CFZ533 with CD40 prevents the binding of CD40 with another protein called CD154 (or also CD40 Ligand), hence prevents the trigger of CD40 CD154 interactions and the subsequent activities which are believed to play an important role in the mechanisms of Sjögren’s syndrome.
  This is the first time that CFZ533 will be tested in patients with primary Sjögren’s syndrome, but it is not the first time that the drug has been given to humans. As of 16-Nov-2013, 36 healthy volunteers have been given intravenous infusion or subcutaneous injection of CFZ533 in a clinical trial. Overall, there have been no clinically significant deviations in clinical laboratory assessments, and the drug was tolerated well.
  The reason for this study is to find out if CFZ533 is safe and effective in patients with primary Sjögren’s syndrome when compared to the placebo treatment. As it is not known whether CFZ533 is effective, we need to make comparisons with a placebo.
  A placebo is a dummy drug with no active medicine inside. A placebo is used to make sure that the changes you report are not happening just by chance

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/0182

• Date of REC Opinion

  23 Jul 2014

• REC opinion

  Further Information Favourable Opinion