Phase II Study Evaluating Safety and Effectiveness of TQH2722 Injection with Background Treatment for Seasonal Allergic Rhinitis

What this Trial Is About

Researchers are evaluating the safety and efficacy of TQH2722 injection combined with background therapy in people with seasonal allergic rhinitis. This multicenter, open-label, Phase II clinical trial aims to enroll 200 to 300 adults aged 18 to 75 who have seasonal allergic rhinitis with poor symptom control or dissatisfaction with symptom management during the previous pollen season. Participants will receive TQH2722 injection, a humanized monoclonal antibody targeting interleukin-4 receptor alpha, administered in treatment cycles lasting two weeks. The study is single-arm and open-label, meaning all participants receive the injection combined with their background treatment without placebo comparison. The treatment period is followed by assessments at baseline, 2 weeks, and 4 weeks to monitor nasal and ocular symptoms, quality of life, and laboratory tests. During the study, participants will be monitored for adverse events, serious adverse events, and changes in laboratory indicators up to 4 weeks after baseline. Nasal and ocular symptom scores will be recorded daily and retrospectively assessed at 2 and 4 weeks. Blood tests for eosinophil counts, immunoglobulin E levels, and lung function tests for those with asthma will be conducted up to 12 weeks. Participants must comply with study visits, symptom diaries, and safety evaluations throughout the trial, which continues until March 2027.

Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis