This study is a multicenter, open-label, Phase II, single-arm clinical trial, with a planned enrollment of 200 to 300 subjects. Its primary objective is to evaluate the safety and efficacy of TQH2722 injection in the treatment of seasonal allergic rhinitis.
Aged 18-75, with no gender restrictions.
Diagnosed with seasonal allergic rhinitis.
Positive allergen test result.
The subjects have sufficient exposure to pollen during the pollen season.
Any abnormal laboratory test value during the screening period or randomization.
Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study results or their interpretation, or hinder the patient's ability to complete the entire study process.
Patients with active autoimmune diseases.
Known or suspected immunosuppressants.
Single group
TQH2722 injection
DrugTQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα).
Number of subjects with incidence of adverse event
Adverse events occurring during treatment.
Number of subjects with incidence of serious adverse event
Serious adverse event occurring during treatment.
Number of subjects with incidence of abnormality check indicators
Number of subjects with incidence of abnormality check indicators: Abnormal examination indicators occurred during treatment.
Retrospective nasal symptom score after treatment for 2 weeks
The average change in the retrospective total nasal symptom score (rTNSS) per day over 2 weeks of treatment compared to baseline. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Retrospective nasal symptom score after treatment for 4 weeks
The average change in the retrospective total nasal symptom score (rTNSS) per day over 4 weeks of treatment compared to baseline. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
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