Study Complete
Sponsor ID
D5180C00009

Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent AsthmaSOURCE

Sponsor ID
D5180C00009
Clinicaltrials.gov ID
NCT03406078
EUCTIS ID
N/A
EudraCT ID
N/A

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

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
150
Additional Study Details

Protocol Summary

Primary Outcome Measures

Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control

Timeframe: Baseline to Week 48

Secondary Outcome Measures

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

Study Documents

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Bakersfield, California, United States, 93301
Status
N/A
Location
Research Site
Newark, Delaware, United States, 19713
Status
N/A
Location
Research Site
Kissimmee, Florida, United States, 34741
Status
N/A
Location
Research Site
Kissimmee, Florida, United States, 34746
Status
N/A
Location
Research Site
Fall River, Massachusetts, United States, 02721
Status
N/A
Location
Research Site
Ann Arbor, Michigan, United States, 48109
Status
N/A
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