A study to investigate the efficacy of QBX258 in Asthma

• Research type

  Research Study

• Full title

  A randomized double-blind multiple-dose placebo-controlled trial to establish the efficacy of QBX258 (combination of VAK694 and QAX576) in asthma that is inadequately controlled with inhaled corticosteroids and long acting beta agonists.

• IRAS ID

  94917

• Contact name

  Andrew Menzies-Gow

• Sponsor organisation

  Novartis

• Eudract number

  2011-003066-32

• Research summary

  This study concerns QBX258, which is a combination of two drugs, VAK694 and QAX576. It is being developed for the treatment of severe asthma. In asthma there is inflammation of the airways which causes a reversible narrowing of the airways. However in severe asthma the narrowing of the airways may become irreversible, causing persistent symptoms of shortness of breath, chest tightness, wheeze and cough. There is currently an unmet need to develop medications which are effective in the treatment of patients with severe asthma who have symptoms which are uncontrolled with currently available medications. VAK694 and QAX576 are proteins (antibodies) which are designed to block the effects of two key mediators of inflammation in the airways of patients with asthma. These proteins are called interleukin 4 and interleukin 13. There is therefore a potential for QBX258 to be an effective treatment for patients with severe asthma. This is not the first time QBX258 will be given to patients with asthma. To date 32 patients with asthma have received QBX258. The purpose of this research study is to evaluate if QBX258 is effective in treating patients with moderate to severe asthma. The study will assess whether it improves symptoms of asthma, lung function, and airways inflammation. We are also investigating the effect of variations in certain genes on the response to treatment with QBX258. The study will take place at 4 research units in London. The study involves several visits to the research unit, with a screening visit, run-in period, 2 baseline visits, 7 treatment period visits, and 4 follow-up visits. Each subject will be in the study for approximately 8-9 months.Approximately 60 patients with severe asthma will participate in the first part of the study, and up to 60 patients may participate in the second part of the study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1904

• Date of REC Opinion

  9 Feb 2012

• REC opinion

  Further Information Favourable Opinion