Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

Phase 3

Completed

Conditions: Severe Asthma

Registration Number: NCT04048343

Lead Sponsor: AstraZeneca

Brief Summary: This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.

Detailed Description: This is open-label, single arm study designed to evaluate the 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 66 subjects will be dosed in Japan. Subjects will receive tezepelumab 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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.

Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score ≥1.5 at screening or on day of registration.

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-yrs. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	From first dose of study drug until last study visit at Week 64	The number of subjects who experienced an AE during on-treatment period was summarised.

Secondary Outcome Measures