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

Severe Asthma Clinical Trial

— NOZOMI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048343
• Other study ID #: D5180C00019
• Status: Completed
• Phase: Phase 3
• Start date: June 10, 2019
• Est. completion date: March 18, 2021

Study information

• Verified date: April 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Drug:
• Biological: Experimental: Tezepelumab
Tezepelumab subcutaneous injection every 4 weeks

Locations

Country	Name	City	State
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Sagamihara-shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinjuku-ku

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Amgen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Adverse Events	The number of subjects who experienced an AE during on-treatment period was summarised.	From first dose of study drug until last study visit at Week 64

External Links

•   CSR Synopsis
•   Related Info
•   Related Info