Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2016
INTERVENTION: investigational material(s) Generic name etc : QGE031 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : QGE031 subcutaneous injection every 4 weeks (QGE031 120 mg per 1 mL liquid in vial) control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Placebo subcutaneous injection every 4 weeks (Placebo to QGE031 0 mg per 1 mL liquid in vial) CONDITION: Asthma PRIMARY OUTCOME: QGE031 compared to placebo in atopic asthma patients on the reduction in rate of severe asthma exacerbations [ Time Frame: Week 52 ] SECONDARY OUTCOME: QGE031 compared to placebo in all asthma patients on the reduction in rate of severe asthma exacerbations [ Time Frame: Week 52 ]; ; QGE031 compared to placebo in non‐atopic asthma patients on the reduction in rate of severe asthma exacerbations [ Time Frame: Week 52 ] INCLUSION CRITERIA: *A diagnosis of allergic asthma, uncontrolled on current medication *History of at least 2 asthma exacerbations during the last 1 year *Forced Expiratory Volume in one second (FEV1) of >= 40% and <= 80% of the predicted normal value; reversibility following administration of bronchodilator
Epistemonikos ID: f21cd7529758748f682c7e04bcc9476567bfbad2
First added on: Aug 26, 2024