Asthma
Conditions
Brief summary
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.
Interventions
DRUGAK139
AK139 regimen 1- subcutaneous injection.
DRUGPlacebo
subcutaneous injection.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs), serious adverse events(SAEs) | Up to week 4 | — |
| Serum AK139 concentration | Up to week 20 | — |
| Immunogenicity characteristics of AK139 | Up to week 20 | Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. |
Countries
China
Contacts
CONTACTGuoqin Wang
Outcome results
None listed