AIN457 to assess safety, tolerability, efficacy & PK in asthma

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo controlled, multiple dose study to evaluate the safety, tolerability, and efficacy of intravenous administration of secukinumab (AIN457) in patients with asthma not adequately controlled with inhaled corticosteroids and long acting betaagonists.

• IRAS ID

  91207

• Contact name

  Ian Pavord

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-003117-41

• Research summary

  Secukinumab (AIN457) is a monoclonal antibody which binds to, and neutralises, human IL-17, a cytokine that has been implicated in neutrophilic inflammation and steroid-resistant airway hyperresponsiveness associated with asthma. Secukinumab has been shown to be effective at reducing the inflammatory response in patients with diseases such as psoriasis and rheumatoid arthritis. This study will be the first time secukinumab will be given specifically to asthma patients. The purpose of the clinical trial is to measure the clinical response to treatment with secukinumab in patients whose moderate to severe asthma is poorly controlled despite being treated with high doses of inhaled corticosteroid combined with long-acting beta agonist. The study is randomised, double blind and placebo controlled to eliminate bias in selecting and evaluating the patients and to evaluate the response due to secukinumab alone. Patients will continue to take their asthma medication throughout the study. After a screening visit, there will be a run-in period where patients will be asked to perform lung function tests twice daily and record their medication use and night awakenings in an electronic diary. If they are able to do this, they will proceed to the baseline visit, treatment, follow up and end of study visits. There will be up to 14 visits in total. Patients will be given an infusion of either secukinumab 10mg/Kg or placebo on 4 occasions during the study. Twice as many patients will receive secukinumab than placebo. During the treatment, follow up and end of study visits, study assessments will include physical examination, vital sign, body temperature, weight and height measurements, ECG, lung function tests, questionnaires, blood and urine collection, nitric oxide test, sputum induction, nasal epithelial brushing and safety monitoring. The study aims to treat 45 patients in 10 study sites. There will be six study sites in the UK.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0098

• Date of REC Opinion

  3 Feb 2012

• REC opinion

  Favourable Opinion