Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent AsthmaSOURCE
Study Details
Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
Protocol Summary
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
Timeframe: Baseline to Week 48
Annualised Asthma Exacerbation Rate (AAER)
Timeframe: Baseline to Week 48
Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48
Timeframe: Baseline to Week 48
Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 48
Timeframe: Week 48
Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 48
Timeframe: Baseline to Week 48
Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Baseline to Week 48
Change From Baseline in Weekly Mean Daily Asthma Symptom Score Via the Daily Asthma Symptom Diary
Timeframe: Baseline to Week 48
Change From Baseline in Weekly Mean Rescue Medication Use
Timeframe: Baseline to Week 48
Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening)
Timeframe: Baseline to Week 48
Change From Baseline in Weekly Mean Number of Night-time Awakening Due to Asthma
Timeframe: Baseline to Week 48
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score
Timeframe: Baseline to Week 48
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score
Timeframe: Baseline to Week 48
Change From Baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) Score
Timeframe: Baseline to Week 48
Number of Participants With Asthma Specific Resource Utilizations
Timeframe: Baseline to Week 48
Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score
Timeframe: Baseline to Week 48
Change From Baseline in FENO
Timeframe: Baseline to Week 48
Change From Baseline in Peripheral Blood Eosinophils
Timeframe: Baseline to Week 48
Change From Baseline From Total Serum IgE
Timeframe: Baseline to Week 48
PK: Serum Trough Concentrations
Timeframe: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 40, Week 48, Week 60
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
Timeframe: Baseline to Week 60