Clinical trial NCT05155020: A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: AK120
Efficacy
Safety
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
timeFrame: At week 12
Secondary outcomes:
measure: Annualized rate of severe exacerbation events within 24 weeks.
timeFrame: Baseline to Week24
measure: Annualized rate of severe exacerbation events within 32 weeks.
timeFrame: Baseline to Week32
measure: Change in pre-bronchodilator FEV1 from baseline to week 32.
timeFrame: Baseline to Week32
measure: Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
timeFrame: Baseline to Week32
measure: Change in post-bronchodilator FEV1 from baseline to week 32.
timeFrame: Baseline to Week32
measure: Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32.
timeFrame: Baseline to Week32
measure: Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.
timeFrame: Baseline to Week32
measure: Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24.
timeFrame: at week 12,week 24
measure: Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) .
timeFrame: Baseline to Week32
measure: Pharmacokinetics (PK): AK120 concentration at different time points.
timeFrame: Baseline to Week32
measure: Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA).
timeFrame: Baseline to Week32
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Jingmei General Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Baotou
country: China
facility: Baogang Hospital, Inner Mongolia, China
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Prople's Hospita
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine,
state: Zhejiang
Study officials:
References: