Status:
COMPLETED
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Amgen
Conditions:
Severe Asthma
Eligibility:
All Genders
12-80 years
Phase:
PHASE3
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 ...
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04048343
Start Date
June 10 2019
End Date
March 18 2021
Last Update
June 1 2022
Active Locations (5)
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1
Research Site
Chūōku, Japan, 103-0022
2
Research Site
Chūōku, Japan, 104-0031
3
Research Site
Sagamihara-shi, Japan, 228-0815
4
Research Site
Shinagawa-ku, Japan, 140-8522