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NCT Number: NCT07436221

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK139

Drug

AK139 regimen 1- subcutaneous injection.

Placebo

Drug

subcutaneous injection.

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

    Time frame: Up to week 20

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

Study contacts

Contact information is provided by the study sponsor or research team.

Guoqin Wang

CONTACT

[email protected]

+86 (0760) 8987 399

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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