AK139 for moderate to severe asthma in adults
Tests AK139 against a placebo in adults with moderate to severe asthma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
Key facts
- Where
- Guangzhou and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07436221, who can take part
Where in China
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
- Shanghai General HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Akeso
- Trial code
- NCT07436221
- Record updated
- 27 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.