QGE031B2204: QGE031 vs placebo in asthma
Research type
Research Study
Full title
A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 s.c. in Asthma Patients Not Adequately Controlled by Medium- or High-dose ICS Plus LABA With or Without OCS
IRAS ID
173710
Contact name
Monica Couto
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-003155-57
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 25 days
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 four different treatment arms containing either of 3 different doses of the study drug QGE031, or placebo (dummy no active drug). Injections will be given every 4 weeks for a period of 52 weeks.
There will be a three in four chance of receiving active drug (QGE031) . Neither doctor nor patient will know which treatment has been allocated.
Patients will visit the hospital clinic 20 times in total over approximately a 72 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 440 adult patients worldwide (approx. 14 from the UK) with a confirmed diagnosis of asthma but who are not adequately controlled with current asthma medication.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1451
Date of REC Opinion
3 Nov 2015
REC opinion
Further Information Favourable Opinion