Severe Asthma
Conditions
Keywords
Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma
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 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.
Interventions
DRUGBiological: Experimental: Tezepelumab
Tezepelumab subcutaneous injection every 4 weeks
Sponsors
Amgen
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subject will be dosed tezepelumab administered subcutaneously
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events | From first dose of study drug until last study visit at Week 64 | The number of subjects who experienced an AE during on-treatment period was summarised. |
Countries
Japan
Participant flow
Recruitment details
A total of 65 subjects fulfilled all inclusion and exclusion criteria and were registered to receive treatment at 5 centres in Japan.
Pre-assignment details
All registered subjects received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Tezepelumab 210mg Q4W Tezepelumab admistered every 4 weeks subcutaneously | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Tezepelumab 210mg Q4W |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 51.3 Years STANDARD_DEVIATION 12.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 65 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 29 / 65 |
| serious Total, serious adverse events | 4 / 65 |
Outcome results
Primary
Number of Subjects With Adverse Events
The number of subjects who experienced an AE during on-treatment period was summarised.
Time frame: From first dose of study drug until last study visit at Week 64
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tezepelumab 210 Q4W | Number of Subjects With Adverse Events | 39 Participants |