NCT07436221Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
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
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 3 Feb 2026
- Start date
- 28 Feb 2026
- Primary completion date
- 27 Dec 2026
- Lead sponsor
- Akeso
- Diseases
- Asthma
- NCT number
- NCT07436221
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From 28 Feb 2026 to the primary completion date, 27 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Other reasons the investigators believe that the participants are not suitable to enrolled in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.