Evaluating Long-term Safety and Effectiveness of TQH2722 Injection for Treating Chronic Sinusitis With or Without Nasal Polyps

What this Trial Is About

Researchers are evaluating the long-term safety, effectiveness, and immune response of two doses of TQH2722 injection in adults with severe chronic sinusitis, with or without nasal polyps. This Phase II, multicenter, randomized trial aims to expand understanding of TQH2722s role in managing this condition over an extended period. Participants receive either 300mg or 600mg of TQH2722 injection every two weeks until week 22, combined with daily use of Mometasone furoate nasal spray at doses of 100-200 mcg until week 32. The study includes two parts A and B, with similar treatment schedules and follow-up visits to monitor the treatment effects. During the study, participants undergo regular assessments including monitoring for treatment-emergent adverse events up to 32 weeks. Researchers measure changes in sinus imaging scores, smell identification tests, symptom scores, nasal polyp sizes, and immune responses. Safety evaluations include laboratory tests and monitoring for serious adverse events. The total study duration includes treatment and follow-up visits over approximately 32 weeks.

Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps