AsthmaPhase 2NCT07436221
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
A Phase 2 study testing AK139 in people with Asthma, run by Akeso at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- AK139
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 28 Feb 2026to 26 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Shanghai General Hospital
Shanghai
About this study
Official 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
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.
- Conditions
- Asthma
- Being tested
- AK139, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK139Drug
AK139 regimen 1- subcutaneous injection.
AK139Drug
AK139 regimen 2- subcutaneous injection.
AK139Drug
AK139 regimen 3- subcutaneous injection.
PlaceboDrug
subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| AK139 regimen 1 | Experimental | Not described Receives: Drug: AK139 |
| AK139 regimen 2 | Experimental | Not described Receives: Drug: AK139 |
| AK139 regimen 3 | Experimental | Not described Receives: Drug: AK139 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in pre-bronchodilator FEV1
Measured: Up to week 12
Absolute change and percent change from baseline in FENO
Measured: Up to week 12
Secondary outcomes (3)
Adverse events (AEs), serious adverse events(SAEs)
Measured: Up to week 4
Serum AK139 concentration
Measured: Up to week 20
Immunogenicity characteristics of AK139
Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Measured: Up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion27 Dec 2026 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436221
- Sponsor's protocol ID
- AK139-201
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07436221
- Acronym / sponsor ID
- AK139-201
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 27 Dec 2026 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AK139 regimen 1 | Experimental | Drug: AK139 |
| AK139 regimen 2 | Experimental | Drug: AK139 |
| AK139 regimen 3 | Experimental | Drug: AK139 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK139AK139 regimen 1- subcutaneous injection. | Drug | AK139 regimen 1 |
| AK139AK139 regimen 2- subcutaneous injection. | Drug | AK139 regimen 2 |
| AK139AK139 regimen 3- subcutaneous injection. | Drug | AK139 regimen 3 |
| Placebosubcutaneous injection. | Drug | Placebo |
Primary outcome
Absolute change from baseline in pre-bronchodilator FEV1
Time frame: Up to week 12
Absolute change and percent change from baseline in FENO
Time frame: Up to week 12
3 secondary outcomes
Adverse events (AEs), serious adverse events(SAEs)
Time frame: Up to week 4
Serum AK139 concentration
Time frame: Up to week 20
Immunogenicity characteristics of AK139
Time frame: Up to week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK139 in people with Asthma, run by Akeso at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoqin Wang (+86 (0760) 8987 399, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in pre-bronchodilator FEV1 (time frame: Up to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.