This is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps.
Inclusion Criteria of Part A
Sign informed consent before the test to fully understand the purpose, process and possible adverse reactions of the test;
Age 18-75 years old (including the threshold), male or female;
Subjects completed prescribed treatment as required and completed Part A end of study (EOS) visit;
In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-related AE led to the discontinuation of TQH2722 therapy, and after discussion between the investigator and sponsor, the subject was deemed unsuitable for continuation of TQH2722 therapy.
The subjects had poor compliance in the main study, and the researchers judged that they could not complete the continuing study.
During the main study (TQH2722-II-02), any severe progression or poorly controlled concomitant disease (such as asthma exacerbation requiring adjustment of background medication) is identified and the subject is deemed unfit to participate by the principal investigator;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 upper limit of normal (ULN);