A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma (NCT07436221) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
China160 participantsStarted 2026-02-28
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosed with asthma at least one year;
. Evidence of the reversibility of airflow limitation meets the requirements of the protocol;
. Pre-bronchodilator forced expiratory volume (FEV1) meets the requirements of the protocol at screening and baseline;
. Asthma Control Questionnaire 5-question version (ACQ-5) score≥1.5 at screening and baseline;
. 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
. Concomitant respiratory diseases that, as determined by investigators, may affect the evaluation of therapeutic effects or safety of the investigational product;
. A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the screening up to and including the baseline;
. Allergic to any component of the investigational product or intolerant to basis treatment;
. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since AK139 is in Phase 2, what do we know so far about its safety profile, and how does that uncertainty compare to the asthma treatments I'm currently on or could start right away?
2This trial measures changes in my lung function using a test called FEV1 and a breath test called FENO — can you explain what improvements in those measurements would actually mean for how I feel day-to-day with my asthma?
3The study isn't recruiting yet, so there could be a waiting period before I could even join — given my current asthma control, is it reasonable to wait, or should we be starting or adjusting a proven treatment now?
4Since this is a Phase 2 trial, it's still focused on confirming that AK139 works and is safe — does that mean I might be taking a bigger risk compared to treatments that are already fully approved for asthma?
5Are there existing asthma therapies, like certain biologics or inhaled corticosteroids, that we haven't tried yet that might be worth pursuing before considering an experimental Phase 2 study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change from baseline in pre-bronchodilator FEV1
Timeframe: Up to week 12
2
Absolute change and percent change from baseline in FENO