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New allergy shot under safety spotlight

NCT ID NCT07459556

Symptom relief Sponsor: Chengdu Kangnuoxing Biopharma,Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test the safety of a new biologic drug called stapokibart, given as a shot, in 400 adults with seasonal allergic rhinitis (SAR). Participants are already prescribed the drug by their doctor. The main goal is to track any side effects. This is an open-label study, meaning everyone knows they are getting the drug.

What this could mean

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

Active substance
Stapokibart (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a safe treatment option for seasonal allergic rhinitis.
What could go wrong
This is an early safety study, not designed to prove the drug works. Side effects or lack of effectiveness may limit its use.

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.

Participants

About 400 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

Feb 2028

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.

Who is studied

Participants who are treated with Stapokibart Injection for SAR at the physician's discretion (according to the China-specific prescribing information).

Ages

18 years and older

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: * Participants aged 18 years or older at the time of informed consent and provide voluntary informed consent to participate in the study before inclusion in the study. * Physician decision to treat the participant with Stapokibart Injection for SAR (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study. Exclusion Criteria: * Known history of allergic reaction to Stapokibart Injection. * Participants currently or plan participating in any interventional clinical trial. * Participants with hematologic malignancies. * Women with pregnant. * Any condition that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.

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Conditions

The condition(s) this trial relates to.

seasonal allergic rhinitis severe acute respiratory syndrome severe cutaneous adverse reaction

As listed by the trial registrant

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

SAR

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Tongren Hospital, CMU

    Beijing, China

    Contact Email: •••••@•••••