New shot aims to tame tough seasonal allergies
NCT ID NCT07291284
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental injection called LP-003 in 546 adults with moderate to severe seasonal allergic rhinitis (hay fever) that standard medications don't manage well. Participants receive either the drug or a placebo, and report their nasal symptoms daily. The goal is to see if LP-003 safely reduces symptoms like sneezing, stuffiness, and runny nose during peak pollen season.
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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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546 people
The number who actually took part.
- Started
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Aug 2024
- 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 65 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: * Male or female, aged 18 to 65 years * Subjects with SAR for at least 2 years * At least one serum-specific IgE test for an allergen associated with the onset of allergic rhinitis during the current season or the same period * Subjects who did not achieve satisfactory efficacy from Standard-of-Care prior to screening * Subjects who experienced nasal symptoms for ≥ 2 days, or nasal and ocular symptoms for ≥ 1 day; with rTNSS ≥ 1 prior to randomization Exclusion Criteria: * Combined with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, a history of acute or chronic sinusitis * Subjects with perennial allergic rhinitis (PAR) * Underwent any nasal or sinus surgery within 1 year prior to screening * Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections * Clinically significant conditions upon the judgement of investigator * Subjects with concomitant asthma who, upon the judgement of investigator, require inhaled corticosteroid treatment during the study * The laboratory results at screening: a) white blood cell (WBC) \< 2.5×10\^9/L; b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.0 ×upper limit of normal (ULN) or total bilirubin \> 1.5 ×ULN; c) Serum creatinine (Cr) \> 1.5 × ULN * Received treatment with similar drugs (e.g., Omalizumab) or used LP-003 Injection within 6 months prior to screening * Received systemic glucocorticoids within 4 weeks prior to screening * Received intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, or antihistamine medications within 1 week prior to randomization * Received traditional Chinese medicine treatment for allergic rhinitis within the 7 days prior to randomization * Received allergen immunotherapy within 6 months prior to screening (for those who have not completed the therapy), or within 3 years prior to screening (for those who have completed the therapy) * Subjects for whom exposure to allergens in the home or work environment are expected to undergo significant changes during the trial, as assessed by the investigator, which may interfere with the evaluation of efficacy * Subjects planning to travel outside their area of residence during the trial to an area without pathogenic pollen, for either 2 consecutive days or a total duration exceeding three days
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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.
Contacts and locations
Locations
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Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital)
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new nasal spray tame seasonal allergy misery?
- Can a pinpoint pollen dose unmask allergy triggers?
- New allergy pill could offer relief from sneezing and stuffy nose
- New injection could tame seasonal allergy symptoms for those failed by standard treatments
- New shot for teen hay fever? early trial underway