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Study Complete
Sponsor ID
D5180C00007

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled AsthmaNAVIGATOR

Sponsor ID
D5180C00007
Clinicaltrials.gov ID
NCT03347279
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
1061
Additional Study Details

Protocol Summary

Primary Outcome Measures

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma

Timeframe: From randomisation to Study Week 52.

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL

Timeframe: From randomisation to Study Week 52.

Secondary Outcome Measures

Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)

Timeframe: From randomisation to Study Week 52

Time to First Asthma Exacerbation

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52

Timeframe: From randomisation to Study Week 52

Activity Impairment at Week 52

Timeframe: From randomisation to Study Week 52

Pharmacokinetics of Tezepelumab

Timeframe: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64

Mean Change From Baseline at Week 52 in EQ-5D-5L VAS

Timeframe: At Study Week 52

Clinicians Global Impression of Change at Week 52

Timeframe: From randomisation to Study Week 52

Patients Global Impression of Change at Week 52

Timeframe: From randomisation to Study Week 52

Patients Global Impression of Severity at Week 52

Timeframe: At Study Week 52

Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)

Timeframe: From randomisation to Study Week 52

Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

Timeframe: From randomisation to Study Week 52

Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52

Timeframe: From randomisation to Study Week 52

Immunogenecity of Tezepelumab

Timeframe: Baseline, and from time of first dose at Week 0 to end of study at Week 64.

Proportion of Subjects Who Had no Asthma Exacerbations

Timeframe: From randomisation to Study Week 52

Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation

Timeframe: From randomisation to Study Week 52

Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation

Timeframe: From randomisation to Study Week 52

Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation

Timeframe: From randomisation to Study Week 52

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Dothan, Alabama, United States, 36303
Status
N/A
Location
Research Site
Foley, Alabama, United States, 36535
Status
N/A
Location
Research Site
Gilbert, Arizona, United States, 85234
Status
N/A
Location
Research Site
Tucson, Arizona, United States, 85724
Status
N/A
Location
Research Site
Bakersfield, California, United States, 93301
Status
N/A
Location
Research Site
Encinitas, California, United States, 92024
Status
N/A
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Study Info
Age
12 - 80 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Nov 2017 - Sep 2020
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Age. 12-80 * Documented physician-diagnosed asthma for at least 12 months * Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months. * Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months. * At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. * Morning pre-BD FEV1 \<80% predicted normal (\<90% for subjects 12-17 yrs) * Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening. * Documented history of at least 2 asthma exacerbation events within 12 months. * ACQ-6 score ≥1.5 at screening and on day of randomization
    Exclusion Criteria:
    * Pulmonary disease other than asthma. * History of cancer. * History of a clinically significant infection. * Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes. * History of chronic alcohol or drug abuse within 12 months. * Hepatitis B, C or HIV. * Pregnant or breastfeeding. * History of anaphylaxis following any biologic therapy. * Subject randomized in the current study or previous tezepelumab studies.