Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Other: Placebo; Biological: Experimental: Tezepelumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03347279

D5180C00007

Details and patient eligibility

About

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

Full description

This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Enrollment: 1,061 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,061 participants in 2 patient groups, including a placebo group

Tezepelumab

Experimental group

Description:

Tezepelumab: Tezepelumab subcutaneous injection

Treatment:

Biological: Experimental: Tezepelumab

Placebo

Placebo Comparator group

Description:

Placebo: Placebo subcutaneous injection

Treatment:

Other: Placebo