NCT04048343

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

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tezepelumab in Japanese Adults and Adolescents With Inadequately Controlled Severe Asthma (NOZOMI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Asthma

Interventions

Type	Name	Description
DRUG	Biological: Experimental: Tezepelumab	Tezepelumab subcutaneous injection every 4 weeks

Timeline

• Start date: 2019-06-10
• Primary completion: 2021-03-18
• Completion: 2021-03-18
• First posted: 2019-08-07
• Last updated: 2022-06-01
• Results posted: 2022-06-01

Locations

5 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study