This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.
At the time of signing the informed consent form, the age is 18 to 75 years old.
Meet the diagnostic criteria for seasonal allergic rhinitis (SAR) as defined in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have a disease duration of at least 2 years.
At the screening visit, the investigator assesses that the subject had poor efficacy with intranasal glucocorticoids and/or other medications for allergic rhinitis (antihistamines, leukotriene receptor antagonists, etc.) during the same pollen season in the past.
The subject has an immunoglobulin E (IgE)-mediated hypersensitivity to at least one pollen allergen in the current season or the same period, which can be confirmed based on the skin prick test (SPT) and/or serum specific IgE results during the screening period (test results within 1 year before randomization are acceptable).
During screening or within 2 weeks prior to the screening visit, the subject has other active rhinitis excluding SAR, including but not limited to infectious rhinitis, drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, dry rhinitis, atrophic rhinitis, etc.
During screening or within 2 weeks prior to the screening visit, there may be other nasal comorbidities or concurrent diseases/states that could affect the judgment of efficacy (including but not limited to nasal polyps, cerebrospinal fluid rhinorrhea, severe nasal septal deviation, status after nasal or sinus surgery within 1 year, etc.), acute/chronic sinusitis (except those deemed non-influential by the investigator), or upper respiratory tract infections.
During screening, there is glaucoma, cataract, ocular simple herpes, other ocular infections such as infectious conjunctivitis, acute conjunctivitis, acute keratitis (except for symptoms related to allergic rhinitis).
During the screening visit, subjects with perennial allergic rhinitis (PAR) allergic to pet hair are included; if the subject currently has no contact with pet hair, they can be enrolled.