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 range18 Years – 65 Years

SexALL

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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;
✕. Other reasons the investigators believe that the participants are not suitable to enrolled in this study.

What they're measuring

Absolute change from baseline in pre-bronchodilator FEV1

Timeframe: Up to week 12

Absolute change and percent change from baseline in FENO

Timeframe: Up to week 12

Trial details

NCT IDNCT07436221

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-27

Contact for this trial

Guoqin Wang

+86 (0760) 8987 399 global.trials@akesobio.com

View on ClinicalTrials.gov More Asthma trials