A Multi-center, Open-label, Phase II, Single-arm Clinical Study Evaluating the Safety and Efficacy of TQH2722 Injection Combined With Background Treatment in Subjects With Seasonal Allergic Rhinitis
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.
• The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or the subject was dissatisfied with the subjective symptom control.
• Screen for subjects who have a morning iTNSS score of ≥4 on the day of screening; at baseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.
• Good compliance during screening/induction period.
• Subjects with comorbid asthma should have stable medication use before the screening period and have their asthma condition assessed as stable by the investigator or specialist.
• The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance.
• The subjects and their partners agree to take effective contraceptive measures throughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial drug).