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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02336425
• Date of registration: 08/01/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma
• Scientific title: A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting ß2-agonist (LABA) With or Without Oral Corticosteroid (OCS)
• Date of first enrolment: September 2015
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02336425
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Russian Federation, Slovakia, South Africa, Spain, United States

Key inclusion & exclusion criteria

Key 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Placebo

Drug: QGE031

Primary Outcome(s)

QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations [Time Frame: Week 52]

Secondary Outcome(s)

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score [Time Frame: 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) [Time Frame: Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)]

QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations [Time Frame: Week 52]

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 Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity) [Time Frame: Week 52]

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ) [Time Frame: 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 Time to First Asthma Exacerbations (by Severity) [Time Frame: Week 52]

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening [Time Frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)]

Response to QGE031 Between Atopic Asthma and Non-atopic Asthma [Time Frame: 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 Diary (ACD) [Time Frame: Over 52 weeks (Treatment) and 20 weeks (follow-up)]

Secondary ID(s)

CQGE031B2204

2014-003155-57

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02336425