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

Phase 2

Terminated

Conditions: Asthma

Interventions: Drug: QGE031
Drug: Placebo

Registration Number: NCT02336425

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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.

Key

Exclusion Criteria

Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QGE031 240 mg	QGE031	QGE031 240 mg subcutaneous injection every 4 weeks
Placebo to QGE031	Placebo	Placebo subcutaneous injection every 4 weeks
QGE031 72 mg	QGE031	QGE031 72 mg subcutaneous injection every 4 weeks
QGE031 24 mg	QGE031	QGE031 24 mg subcutaneous injection every 4 weeks

Primary Outcome Measures

Name	Time	Method
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations	Week 52

Secondary Outcome Measures

Name	Time	Method
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score	Over 52 weeks (Treatment) and 20 weeks (follow-up)
Response to QGE031 Between Atopic Asthma and Non-atopic Asthma	Over 52 weeks (treatment) and 20 weeks (follow up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)	Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)	Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)	Week 52
QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations	Week 52
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations	Week 52
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)	Over 52 weeks (Treatment) and 20 weeks (follow-up)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)	Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening	Over 52 weeks (Treatment) and 20 weeks (follow-up)