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

Akeso19 sites in 1 country1 target enrollmentFebruary 11, 2022

ConditionsAsthma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: Akeso
Enrollment: 1
Locations: 19
Primary Endpoint: Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 11, 2022

End Date

August 5, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.

Time Frame: At week 12

Secondary Outcomes

Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.(Baseline to Week32)
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)
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)