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

NCT ID: NCT05155020

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2022-08-05

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AK120 regimen 1

Group Type: EXPERIMENTAL

AK120

Intervention Type: BIOLOGICAL

AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.

AK120 regimen 2

Group Type: EXPERIMENTAL

AK120

Intervention Type: BIOLOGICAL

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

AK120 regimen 3

Group Type: EXPERIMENTAL

AK120

Intervention Type: BIOLOGICAL

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.

Interventions

AK120

AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.

Intervention Type: BIOLOGICAL

AK120

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

Intervention Type: BIOLOGICAL

AK120

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

Intervention Type: BIOLOGICAL

Placebo

Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Jingmei General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Cangzhou People's Hospital

Cangzhou, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Luoyang Central Hospital

Luoyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Baogang Hospital, Inner Mongolia, China

Baotou, Inner Mongolia, China

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Jiangxi Provincial Prople's Hospita

Nanchang, Jiangxi, China

Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Jilin Province People's Hospital

Changchun, Jilin, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Second Affiliated Hospital Zhejiang University School of Medicine,

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

AK120-201

Identifier Type: -

Identifier Source: org_study_id