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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
TQH2722 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.
Time frame: Up to 32 weeks
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).
Time frame: Up to 32 weeks
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).
Time frame: Up to 32 weeks
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.
Time frame: Up to 24 weeks
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.
Time frame: Up to 32 weeks
Changes in Nasal Total Symptom Score from baseline
Changes in subjects' Nasal Total Symptom Score from baseline. The total score is 0-9 points, with the higher score meaning the more severe symptoms.
Time frame: Up to 32 weeks
Changes in the sinusitis Visual Analogue Scale (VAS) score from baseline
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe First People's Hospital of Foshan
Foshan, Guangdong, China
NOT_YET_RECRUITINGThe Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHebei Medical University Third Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGCangzhou Central Hospital
Cangzhou, Heibei, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of science and technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGRenmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGLoudi Central Hospital
Changsha, Hunan, China
NOT_YET_RECRUITING...and 18 more locations
Changes in the sinusitis Visual Analogue Scale (VAS) score from baseline were measured at each evaluation time point. The total score is 0-10 points, with the higher score meaning the more severe symptoms.
Time frame: Up to 32 weeks
Immunogenicity: The incidence of drug-resistant antibodies (ADA) and their titers, and the incidence of neutralizing antibodies (Nab).
Immunogenicity: The incidence of drug-resistant antibodies (ADA) and their titers, and the incidence of neutralizing antibodies (Nab) in subject. If the subject tests positive for ADA, neutralizing antibodies are added.
Time frame: 0h (The first dose), D113, D169 and during withdrawal
Changes in nasal polyp scores of subjects with chronic sinusitis with nasal polyps (CRSwNP) in part A
Changes in nasal polyp scores of subjects with chronic sinusitis with nasal polyps (CRSwNP) at each evaluation time point were compared with baseline values (TQH2722-II-02 in the main study and baseline values in this study, respectively).
Time frame: Weekends 0, 8, 16, 24 and 32
Changes in Sino-nasal Outcome Test (SNOT-22) in part A
Changes in Sino-nasal Outcome Test (SNOT-22) from baseline for subjects at each evaluation time point.
Time frame: Weekends 0, 8, 16, 24 and 32
Changes in nasal congestion score (NCS) in part A from baseline
The changes in nasal congestion score (NCS) from baseline at each evaluation time point in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Time frame: Up to 32 weeks
Changes in nasal/posterior runny nose scores in part A from baseline
Changes in subjects' nasal/posterior runny nose scores from baseline at each evaluation time point. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Time frame: Up to 32 weeks
Changes in the anosmia score in part A from baseline
The changeS in the anosmia score from baseline at each evaluation time point in part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Time frame: Up to 32 weeks
Changes of olfactory loss score in part B from baseline
In Part B, the change of subjects' olfactory loss score from baseline (using the main study TQH2722-II-02 and the baseline value in this study, respectively) at each evaluation time point. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Time frame: Up to 32 weeks
Changes in nasal endoscopic modified Lund-Kennedy scores in part B
In Part B, changes in subjects' nasal endoscopic modified Lund-Kennedy scores from baseline (using the main study TQH2722-II-02 and the baseline in this study, respectively) at each evaluation time point are measured. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
Time frame: Weekends 0, 8, 16, 24 and 32
Changes in Sino-nasal Outcome Test (SNOT-22) in part B
In Part B, change from baseline in Sino-nasal Outcome Test (SNOT-22) for subjects at each evaluation time point.
Time frame: Weekends 0, 8, 16, 24 and 32