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Not yet recruitingNCT07436221Updated Feb 27, 2026

A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma

A Phase 2 interventional study of AK139 and AK139 in Asthma, sponsored by Akeso. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Akeso · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 160 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosed with asthma at least one year;
  2. Evidence of the reversibility of airflow limitation meets the requirements of the protocol;
  3. Pre-bronchodilator forced expiratory volume (FEV1) meets the requirements of the protocol at screening and baseline;
  4. Asthma Control Questionnaire 5-question version (ACQ-5) score≥1.5 at screening and baseline;
  5. 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

Exclusion Criteria:

  1. Concomitant respiratory diseases that, as determined by investigators, may affect the evaluation of therapeutic effects or safety of the investigational product;
  2. A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the screening up to and including the baseline;
  3. Allergic to any component of the investigational product or intolerant to basis treatment;
  4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to;
  5. Other reasons the investigators believe that the participants are not suitable to enrolled in this study.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    AK139 regimen 1

    Drug: AK139

  • Experimental
    AK139 regimen 2

    Drug: AK139

  • Experimental
    AK139 regimen 3

    Drug: AK139

  • Experimental
    Placebo

    Drug: Placebo

Interventions

  • DrugAK139

    AK139 regimen 1- subcutaneous injection.

  • DrugAK139

    AK139 regimen 2- subcutaneous injection.

  • DrugAK139

    AK139 regimen 3- subcutaneous injection.

  • DrugPlacebo

    subcutaneous injection.

06

What researchers measure

Primary outcomes

  1. Absolute change from baseline in pre-bronchodilator FEV1

    Time frame: Up to week 12

  2. Absolute change and percent change from baseline in FENO

    Time frame: Up to week 12

Secondary outcomes

  1. Adverse events (AEs), serious adverse events(SAEs)

    Time frame: Up to week 4

  2. Serum AK139 concentration

    Time frame: Up to week 20

  3. Immunogenicity characteristics of AK139

    Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.

    Time frame: Up to week 20

07

Study locations

2 sites
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, China
  • Shanghai General Hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07436221
Lead sponsor
Akeso
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Feb 28, 2026 (estimated)
Primary completion
Dec 27, 2026 (estimated)
Completion
Feb 26, 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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