This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe asthma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Diagnosed with asthma at least one year;
2. Evidence of the reversibility of airflow limitation meets the requirements of the protocol;
3. Pre-bronchodilator forced expiratory volume (FEV1) meets the requirements of the protocol at screening and baseline;
4. Asthma Control Questionnaire 5-question version (ACQ-5) score≥1.5 at screening and baseline;
5. The participants agree to use highly effective contraception methods from the moment of signing of the ICF to 3 months after the last dose of the investigational product.
Exclusion Criteria:
1. Concomitant respiratory diseases that, as determined by investigators, may affect the evaluation of therapeutic effects or safety of the investigational product;
2. A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the screening up to and including the baseline;
3. Allergic to any component of the investigational product or intolerant to basis treatment;
4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to;
5. Other reasons the investigators believe that the participants are not suitable to enrolled in this study.
Primary outcome measure(s)
Absolute change from baseline in pre-bronchodilator FEV1 — Up to week 12
Absolute change and percent change from baseline in FENO — Up to week 12
Trial sites (2)
Facility
City
Region
Status
The First Affiliated Hospital of Guangzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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