New injection could tame seasonal allergy symptoms for those failed by standard treatments
NCT ID NCT07688772
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 196 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Tongren Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100005, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, randomized, double-blind, placebo-controlled phase IIb/III study to assess the efficacy and safety of PG-011 nasal spray in adults with moderate to severe seasonal allergic rhinitis
- Can a pinpoint pollen dose unmask allergy triggers?
- New allergy pill could offer relief from sneezing and stuffy nose
- New shot for teen hay fever? early trial underway
- Nasal spray test could make allergy shots smarter and cheaper
- New allergy drug AK139 aims to stop sneezing and stuffy noses