Clinical trial NCT04048343: Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
Official title: A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tezepelumab in Japanese Adults and Adolescents With Inadequately Controlled Severe Asthma (NOZOMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Asthma
Keywords: Asthma
Uncontrolled Asthma
Severe Uncontrolled Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2019-08-07
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subject will be dosed tezepelumab administered subcutaneously
Primary purpose: TREATMENT

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.

Eligibility 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.

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

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: From first dose of study drug until last study visit at Week 64
Secondary outcomes:
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Sagamihara-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
Study officials:
affiliation: Tokyo Shinagawa Hospital Medical Corporation Association, Japan
name: Masaharu Shinkai, MD
role: PRINCIPAL_INVESTIGATOR
References: