New injection could tame seasonal allergy symptoms for those failed by standard treatments

NCT ID NCT07688772

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This Phase 3 trial tests an investigational injection called SHR-1819 in adults aged 18 to 75 with seasonal allergic rhinitis (hay fever) who haven't gotten enough relief from standard treatments like nasal sprays or antihistamines. The study compares the drug to a placebo to see if it reduces nasal symptoms such as sneezing and congestion, as well as eye symptoms, over two to four weeks. Researchers will also monitor safety and how the body processes 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
SHR-1819 injection
What this could lead to
If effective, SHR-1819 could offer a new treatment option for people with seasonal allergies who don't get relief from standard nasal sprays or antihistamines.
What could go wrong
This is an early Phase 3 trial, so the drug may not prove more effective than placebo. Side effects are possible, and results may not apply to all allergy sufferers.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 196 people

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

Started

Aug 2026

Expected to finish

Dec 2026

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 75 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. Age 18 to 75 years (inclusive) at the time of signing the Informed Consent Form, of any sex; 2. Meet the diagnostic criteria for Seasonal Allergic Rhinitis (SAR) as defined in the "Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)", with or without allergic conjunctivitis; 3. The investigator assesses that the participant has had a poor response to intranasal corticosteroids and/or other medications for allergic rhinitis (antihistamines, leukotriene receptor antagonists, etc.) during the same pollen season in previous years; 4. Participants exhibit an immunoglobulin E-mediated hypersensitivity reaction to at least one seasonal pollen allergen; 5. Willing and able to complete the patient diary as required by the protocol during the study; the participant voluntarily signs the Informed Consent Form (ICF) before any study-related procedures begin, can communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; 6. Female participants of childbearing potential and male participants whose partners are women of childbearing potential must agree to use the contraceptive measures specified in the protocol from the signing of the ICF until 3 months after the last dose. Exclusion Criteria: 1. At screening or within 2 weeks prior to the screening visit, the participant has other active rhinitis besides SAR; 2. At screening or within 2 weeks prior to the screening visit, there may be other nasal comorbidities or concurrent diseases/conditions that could affect the efficacy assessment, acute/chronic sinusitis, or upper respiratory tract infection; 3. Has glaucoma, cataract, ocular herpes simplex, other ocular infections such as infectious conjunctivitis, acute conjunctivitis, or acute keratitis at screening; 4. History of Vernal Keratoconjunctivitis (VKC) and/or Atopic Keratoconjunctivitis (AKC) within 6 months prior to the screening visit; 5. Use of Monoamine Oxidase Inhibitors within 2 weeks prior to the screening visit; 6. Initiation of immunotherapy within 4 weeks prior to the screening visit or planned receipt of immunotherapy during the study period; 7. Receipt of an investigational drug or medical device treatment within 8 weeks or 5 half-lives (if the half-life is known) prior to the screening visit, whichever is longer. Participants who participated in a clinical study but only signed the Informed Consent Form (ICF), which can demonstrate screening failure and no drug administration, may be included; 8. Vaccination with or exposure to other live or live attenuated vaccines within 3 months prior to the screening visit, or participation in a vaccine clinical study; 9. Underwent major surgery within 3 months prior to the screening visit, or plan to undergo major surgery during the study period; 10. Diagnosis of active tuberculosis (TB) within 6 months prior to the screening visit; 11. Malignancy or history of malignancy; 12. Pregnant or breastfeeding women; 13. The investigator judges that there are conditions affecting the safety and efficacy evaluation of the study drug, as well as any other conditions that may lead to the participant's non-compliance with the study procedures and diary completion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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 Tongren Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100005, China

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