A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma

Asthma Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05155020
• Other study ID #: AK120-201
• Status: Terminated
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Asthma

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