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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK120
AK120
AK120
Placebo
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring AK120, Efficacy, Safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of Anhui Medical University
  • Beijing Jingmei General Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Cangzhou People's Hospital
  • The Second Hospital of Hebei Medical University
  • Luoyang Central Hospital
  • Henan Provincial People's Hospital
  • Baogang Hospital, Inner Mongolia, China
  • Inner Mongolia People's Hospital
  • Zhongda Hospital Southeast University
  • Jiangxi Provincial Prople's Hospita
  • Jiangxi Pingxiang People's Hospital
  • Jilin Province People's Hospital
  • Shanghai General Hospital
  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Zhongshan Hospital Fudan University
  • First Hospital of Shanxi Medical University
  • The Second Affiliated Hospital Zhejiang University School of Medicine,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AK120 regimen 1

AK120 regimen 2

AK120 regimen 3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Annualized rate of severe exacerbation events within 24 weeks.
Annualized rate of severe exacerbation events within 32 weeks.
Change in pre-bronchodilator FEV1 from baseline to week 32.
Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
Change in post-bronchodilator FEV1 from baseline to week 32.
Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32.
Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.
Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24.
Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) .
Pharmacokinetics (PK): AK120 concentration at different time points.
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA).

Full Information

First Posted
December 1, 2021
Last Updated
October 10, 2022
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT05155020
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
The clinical development strategy has been changed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
AK120, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AK120 regimen 1
Arm Type
Experimental
Arm Title
AK120 regimen 2
Arm Type
Experimental
Arm Title
AK120 regimen 3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
AK120
Intervention Description
AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.
Intervention Type
Biological
Intervention Name(s)
AK120
Intervention Description
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
Intervention Name(s)
AK120
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.
Primary Outcome Measure Information:
Title
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
Time Frame
At week 12
Secondary Outcome Measure Information:
Title
Annualized rate of severe exacerbation events within 24 weeks.
Time Frame
Baseline to Week24
Title
Annualized rate of severe exacerbation events within 32 weeks.
Time Frame
Baseline to Week32
Title
Change in pre-bronchodilator FEV1 from baseline to week 32.
Time Frame
Baseline to Week32
Title
Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
Time Frame
Baseline to Week32
Title
Change in post-bronchodilator FEV1 from baseline to week 32.
Time Frame
Baseline to Week32
Title
Change in fractional exhaled nitric oxide (FeNO) from baseline to week 32.
Time Frame
Baseline to Week32
Title
Changes in asthma control questionnaire (ACQ-5) scores from baseline to week 32.
Time Frame
Baseline to Week32
Title
Change in standardized version of the asthma quality of life (AQLQ-s) scores from baseline at week 12 and 24.
Time Frame
at week 12,week 24
Title
Safety assessment: treatment-emergent adverse events (TEAE), serious adverse events (SAE) .
Time Frame
Baseline to Week32
Title
Pharmacokinetics (PK): AK120 concentration at different time points.
Time Frame
Baseline to Week32
Title
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK120 antibody (ADA).
Time Frame
Baseline to Week32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. Key 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.
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Jingmei General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Cangzhou People's Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Baogang Hospital, Inner Mongolia, China
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Provincial Prople's Hospita
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine,
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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