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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05155020
Other study ID # AK120-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 11, 2022
Est. completion date August 5, 2022

Study information

Verified date October 2022
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 1
Est. completion date August 5, 2022
Est. primary completion date August 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AK120
AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.
AK120
AK120 regimen 2(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
AK120
AK120 regimen 3(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
Placebo
Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.

Locations

Country Name City State
China Baogang Hospital, Inner Mongolia, China Baotou Inner Mongolia
China Beijing Jingmei General Hospital Beijing Beijing
China Cangzhou People's Hospital Cangzhou Hebei
China Jilin Province People's Hospital Changchun Jilin
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China The Third Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou Zhejiang
China The Second Hospital of Anhui Medical University Hefei Anhui
China Inner Mongolia People's Hospital Hohhot Inner Mongolia
China Luoyang Central Hospital Luoyang Henan
China Jiangxi Provincial Prople's Hospita Nanchang Jiangxi
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Jiangxi Pingxiang People's Hospital Pingxiang Jiangxi
China Shanghai General Hospital Shanghai Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Zhongshan Hospital Fudan University Shanghai Shanghai
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China First Hospital of Shanxi Medical University Taiyuan Shanxi
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12. At week 12
Secondary Annualized rate of severe exacerbation events within 24 weeks. Baseline to Week24
Secondary Annualized rate of severe exacerbation events within 32 weeks. Baseline to Week32
Secondary Change in pre-bronchodilator FEV1 from baseline to week 32. Baseline to Week32
Secondary Percentage change in pre-bronchodilator FEV1 from baseline to week 32. Baseline to Week32
Secondary Change in post-bronchodilator FEV1 from baseline to week 32. Baseline to Week32
Secondary Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32. Baseline to Week32
Secondary Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32. Baseline to Week32
Secondary 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
Secondary Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) . Baseline to Week32
Secondary Pharmacokinetics (PK): AK120 concentration at different time points. Baseline to Week32
Secondary Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA). Baseline to Week32
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