severe asthma
Conditions
Interventions
investigational material(s)
Generic name etc : tezepelumab
INN of investigational material : tezepelumab
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administra
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 microgram 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Countries
Japan
Outcome results
None listed