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);
Single group
300mg/600mg of TQH2722 injection
DrugTQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
Treatment emergent adverse events (TEAE)
Frequency of treatment emergent adverse events (TEAE) occurring during treatment.
Serious adverse events (SAEs)
The frequency of serious adverse events (SAEs) that occurred during treatment in subjects with chronic sinusitis with nasal polyps (CRSwNP) or chronic sinusitis without nasal polyps (CRSsNP).
Abnormal laboratory test indicators
Abnormal laboratory test indicators during treatment in subjects with chronic sinusitis with nasal polyps (CRSwNP) or chronic sinusitis without nasal polyps (CRSsNP).
Changes in Lund Mackay score assessed by CT from baseline
Change in Lund Mackay score assessed by CT from baseline. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
Changes in the University of Pennsylvania Smell Identification Test (UPSIT)
The change in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline (main study TQH2722-II-02 and baseline in this study, respectively) at each evaluation time point.
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