CQGE031B2201: QGE031 in asthma patients on inadequate ICS/LABA

• Research type

  Research Study

• Full title

  A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031 in asthma patients not adequately controlled with high-dose inhaled corticosteroids and long acting ß2-agonists.

• IRAS ID

  114037

• Contact name

  Anzal Qurbain

• Eudract number

  2012-002298-69

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Asthma is a chronic inflammatory disorder which is characterized by inflamed and hyper-responsive airways. Airflow limitation occurs as a result of obstruction or narrowing of the airways, when exposed to precipitating factors. Patients suffer episodes of exacerbations (attacks) but the inflammatory condition is long lasting. Despite existing therapies there is still significant unmet medical needs in asthma, with an estimated 300 million people affected worldwide (GINA 2011). It is thought that QGE031 may help asthma patients, by reducing the blood levels of some body chemicals (including immunoglobulin E) related to an allergic reaction. QGE031 has similarities to Omalizumab (also called ??Xolair©?). Omalizumab is a monoclonal antibody that is approved for the treatment of asthma. The benefits of Omalizumab are in patients with allergic (IgE driven) asthma not controlled with available inhaled medications. It is hoped that the tighter binding capacity of QGE031 for IgE will make it more effective in controlling asthma. Eligible patients will be randomly allocated to receive one of fourteen treatment arms containing either of 6 different doses of the study drug QGE031, Omalizumab or placebo (dummy no active drug). Injections will be given biweekly on 8 occasions. There will be a 1 in 2 chance of receiving QGE031, 1 in 4 chance of receiving Omalizumab and 1 in 5 chance of receiving placebo. Neither doctor nor patient will know which treatment has been allocated. Patients will visit the hospital clinic 12 times in total over approximately a 34 week period. Assessments include skin prick tests, physical examinations, blood pressure, pulse, lung function tests, blood and urine tests, completion of health related questionnaires, injection site local symptom pages and diaries. The study will involve approximately 457 adult patients worldwide (9-15 from the UK) with a confirmed diagnosis of asthma but who are not adequately controlled with current asthma medication.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0633

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Further Information Favourable Opinion