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New allergy drug AK139 aims to stop sneezing and stuffy noses

NCT ID NCT07436234

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new medicine called AK139 for people with moderate to severe seasonal allergic rhinitis (hay fever). About 111 adults aged 18-65 with at least a 2-year history of seasonal allergies will receive either AK139 or a placebo. The main goal is to see if AK139 reduces daily nasal symptoms like sneezing, itching, and congestion over 2 weeks, and to check for side effects.

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 111 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

May 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. Male or female aged 18-65. 2. Able to understand the study and voluntarily sign the ICF; 3. Diagnosed SAR according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have SAR history at least two years; 4. Have immunoglobulin E (Ig E)-mediated hypersensitivity to at least one pollen allergen in the current environment; 5. The SAR symptoms of participants remained inadequately control ledafter nasal spray corticosteroids and/or other SAR medications treatment throughout the previous same pollen season; 6. Adequate pollen exposure during the pollen season. 7. The SAR symptoms scores of the participants meet the requirements of the protocol at screening and baseline. 8. During the screening/run-in period, participants must complete at least 80% of the assessments in the diary card; 9. 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. Type of rhinitis other than allergic rhinitis within 2 weeks before screening; 2. Allergic to any component of the investigational drug or intolerant to basis treatment.. 3. Concomitant or associated nasal diseases/conditions that, as determined by investigators, may affect the severity of the disease and the evaluation of therapeutic effects. 4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. 5. Other reasons the investigators believes that the participants is not suitable to enrolled in this study.

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Conditions

The condition(s) this trial relates to.

seasonal allergic rhinitis

As listed by the trial registrant

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

Seasonal allergic rhinitis

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Tong-Ren hospital

    Beijing, China

More trials for these conditions

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