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

February 25, 2026 updated by: Akeso

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
subcutaneous injection.
Experimental: AK139 regimen 1
Drug: AK139
AK139 regimen 1- subcutaneous injection.
Drug: AK139
AK139 regimen 2- subcutaneous injection.
Drug: AK139
AK139 regimen 3- subcutaneous injection.
Experimental: AK139 regimen 2
Drug: AK139
AK139 regimen 1- subcutaneous injection.
Drug: AK139
AK139 regimen 2- subcutaneous injection.
Drug: AK139
AK139 regimen 3- subcutaneous injection.
Experimental: AK139 regimen 3
Drug: AK139
AK139 regimen 1- subcutaneous injection.
Drug: AK139
AK139 regimen 2- subcutaneous injection.
Drug: AK139
AK139 regimen 3- subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in pre-bronchodilator FEV1
Time Frame: Up to week 12
Up to week 12
Absolute change and percent change from baseline in FENO
Time Frame: Up to week 12
Up to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs), serious adverse events(SAEs)
Time Frame: Up to week 4
Up to week 4
Serum AK139 concentration
Time Frame: Up to week 20
Up to week 20
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.
Up to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

December 27, 2026

Study Completion (Estimated)

February 26, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK139-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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