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New asthma drug AK139 enters phase 2 trial – hope for better lung function?

NCT ID NCT07436221

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study tests a new drug called AK139 in 160 people with moderate to severe asthma. Participants receive either AK139 or a placebo by injection under the skin. The trial measures changes in lung function and asthma control over time, while also checking for side effects. It aims to see if AK139 can help manage asthma better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK139 (a drug given by injection under the skin)
What this could lead to
If successful, this could lead to a new treatment option for people with moderate to severe asthma, helping to improve lung function and control symptoms.
What could go wrong
This is an early Phase 2 trial with only 160 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.