This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma.
This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study. The purpose of this study is to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma and not adequately controlled with current stable medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers.Subjects will be randomized to receive AK120 or placebo subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.
AK120 regimen 2(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
AK120 regimen 3(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Jingmei General Hospital
Beijing, Beijing Municipality, China
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
Time frame: At week 12
Annualized rate of severe exacerbation events within 24 weeks.
Time frame: Baseline to Week24
Annualized rate of severe exacerbation events within 32 weeks.
Time frame: Baseline to Week32
Change in pre-bronchodilator FEV1 from baseline to week 32.
Time frame: Baseline to Week32
Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
Time frame: Baseline to Week32
Change in post-bronchodilator FEV1 from baseline to week 32.
Time frame: Baseline to Week32
Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32.
Time frame: Baseline to Week32
Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.
Time frame: Baseline to Week32
Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24.
Time frame: at week 12,week 24
Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) .
Time frame: Baseline to Week32
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Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Baogang Hospital, Inner Mongolia, China
Baotou, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
...and 9 more locations
Pharmacokinetics (PK): AK120 concentration at different time points.
Time frame: Baseline to Week32
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA).
Time frame: Baseline to Week32