A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
- Conditions
- Asthma
- Interventions
- Biological: AK120Biological: Placebo
- Registration Number
- NCT05155020
- Lead Sponsor
- Akeso
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Male or female subjects aged ≥18 years old and ≤75 years old;
- 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;
- Blood eosinophil≥ 200 cells per microliter within 6 months before screening;
- 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;
- Asthma was inadequately controlled;
- 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
- Subjects with lung diseases other than asthma, which may affect the subject's health or end point evaluation of the study;
- Subjects had severe exacerbation events or systemic glucocorticoids usage within 1 month before randomization;
- Respiratory tract infection and any serious infection within 1 month before randomization;
- Subjects with parasitic infection, active tuberculosis infection, Hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis positive confirmation test;
- Known or suspected history of immunosuppression;
- History of malignant tumors;
- A history of smoking: those who had quit smoking for ≤ 6 months before screening, or smoking history > 10 pack per year;
- Previous treatment with interleukin-4 (IL-4) or interleukin-13 (IL-13) inhibitors, and inadequate washout period of other biologic therapy;
- Allergen immunotherapy within 3 months before randomization;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK120 regimen 2 AK120 - AK120 regimen 3 AK120 - Placebo Placebo - AK120 regimen 1 AK120 -
- Primary Outcome Measures
Name Time Method Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12. At week 12
- Secondary Outcome Measures
Name Time Method Annualized rate of severe exacerbation events within 24 weeks. Baseline to Week24 Annualized rate of severe exacerbation events within 32 weeks. Baseline to Week32 Percentage change in pre-bronchodilator FEV1 from baseline to week 32. Baseline to Week32 Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) . Baseline to Week32 Change in pre-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 Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA). Baseline to Week32 Change in post-bronchodilator FEV1 from baseline to week 32. Baseline to Week32 Pharmacokinetics (PK): AK120 concentration at different time points. Baseline to Week32
Trial Locations
- Locations (19)
Inner Mongolia People's Hospital
🇨🇳Hohhot, Inner Mongolia, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Jingmei General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Cangzhou People's Hospital
🇨🇳Cangzhou, Hebei, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Luoyang Central Hospital
🇨🇳Luoyang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Baogang Hospital, Inner Mongolia, China
🇨🇳Baotou, Inner Mongolia, China
Jiangxi Provincial Prople's Hospita
🇨🇳Nanchang, Jiangxi, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital Zhejiang University School of Medicine,
🇨🇳Hangzhou, Zhejiang, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China