Asthma
Conditions
Keywords
AK120, Efficacy, Safety
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAK120
AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.
BIOLOGICALPlacebo
Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female subjects aged ≥18 years old and ≤75 years old; 2. Asthma was diagnosed ≥ 12 months before screening, current stable treatment with medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers ≥ 3 months; 3. Blood eosinophil≥ 200 cells per microliter within 6 months before screening; 4. During the screening, 40% of the predicted normal value \< pre-bronchodilator FEV1 \< 80% of the predicted normal value, within 12 months before randomization, reversible airflow restriction was recorded; 5. Asthma was inadequately controlled; 6. For women with childbearing potential, they are not pregnant or lactating, and the subjects and their partners voluntarily take effective contraceptive measures judged by the investigators during the treatment and at least 3 months after last dose. Key
Exclusion criteria
1. Subjects with lung diseases other than asthma, which may affect the subject's health or end point evaluation of the study; 2. Subjects had severe exacerbation events or systemic glucocorticoids usage within 1 month before randomization; 3. Respiratory tract infection and any serious infection within 1 month before randomization; 4. Subjects with parasitic infection, active tuberculosis infection, Hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis positive confirmation test; 5. Known or suspected history of immunosuppression; 6. History of malignant tumors; 7. A history of smoking: those who had quit smoking for ≤ 6 months before screening, or smoking history \> 10 pack per year; 8. Previous treatment with interleukin-4 (IL-4) or interleukin-13 (IL-13) inhibitors, and inadequate washout period of other biologic therapy; 9. Allergen immunotherapy within 3 months before randomization; 10. Progressive or uncontrolled other diseases or any other conditions or abnormal laboratory tests for which the investigator assess that the subjects are not suitable to enrol in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12. | At week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of severe exacerbation events within 24 weeks. | Baseline to Week24 |
| Annualized rate of severe exacerbation events within 32 weeks. | Baseline to Week32 |
| Change in pre-bronchodilator FEV1 from baseline to week 32. | Baseline to Week32 |
| Percentage change in pre-bronchodilator FEV1 from baseline to week 32. | Baseline to Week32 |
| Change in post-bronchodilator FEV1 from baseline to week 32. | Baseline to Week32 |
| Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32. | Baseline to Week32 |
| Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32. | Baseline to Week32 |
| Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24. | at week 12,week 24 |
| Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) . | Baseline to Week32 |
| Pharmacokinetics (PK): AK120 concentration at different time points. | Baseline to Week32 |
| Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA). | Baseline to Week32 |
Countries
China
Outcome results
None listed