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Study Complete
Sponsor ID
D5180C00019

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

Sponsor ID
D5180C00019
Clinicaltrials.gov ID
NCT04048343
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
65
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Subjects With Adverse Events

Timeframe: From first dose of study drug until last study visit at Week 64

Secondary Outcome Measures
Not Available

Study Documents

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Locations

Location
Status
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Location
Research Site
Chūōku, Japan, 103-0022
Status
N/A
Location
Research Site
Chūōku, Japan, 104-0031
Status
N/A
Location
Research Site
Sagamihara-shi, Japan, 228-0815
Status
N/A
Location
Research Site
Shinagawa-ku, Japan, 140-8522
Status
N/A
Location
Research Site
Shinjuku-ku, Japan, 169-0073
Status
N/A
Study Info
Age
12 - 80 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Jun 2019 - Mar 2021
    Inclusion and Exclusion 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