A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT07436221
- Run by
- Akeso
- People needed
- 160
- Starts
- 2026-02-28
- Expected to finish
- 2027-02-26
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Other reasons the investigators believe that the participants are not suitable to enrolled in this study.
Where it is running
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
- Shanghai General Hospital — Shanghai, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.