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A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma
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
1 other identifier
interventional
1
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Feb 2022
Shorter than P25 for phase_2 asthma
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
February 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2022
CompletedOctober 12, 2022
October 1, 2022
6 months
December 1, 2021
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline at week 12.
At week 12
Secondary Outcomes (11)
Annualized rate of severe exacerbation events within 24 weeks.
Baseline to Week24
Annualized rate of severe exacerbation events within 32 weeks.
Baseline to Week32
Change in pre-bronchodilator FEV1 from baseline to week 32.
Baseline to Week32
Percentage change in pre-bronchodilator FEV1 from baseline to week 32.
Baseline to Week32
Change in post-bronchodilator FEV1 from baseline to week 32.
Baseline to Week32
- +6 more secondary outcomes
Study Arms (4)
AK120 regimen 1
EXPERIMENTALAK120 regimen 2
EXPERIMENTALAK120 regimen 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (19)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 13, 2021
Study Start
February 11, 2022
Primary Completion
August 5, 2022
Study Completion
August 5, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share