This study aims to evaluate the efficacy and safety of TQC2731 injection in the treatment of chronic sinusitis with nasal polyps.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Treatment-related adverse event rate
The frequency of treatment-related adverse events (TEAEs) occurring during treatment at each evaluation time point.
Time frame: Up to thirty six weeks
Treatment-related serious adverse events rate
The frequency of serious adverse events (SAEs) occurring during treatment at each evaluation time point.
Time frame: Up to thirty six weeks
Abnormal laboratory test indicators
The number and severity of abnormal laboratory test indicators.
Time frame: Up to thirty six weeks
Nasal Polyp Score (NPS)
NPS is the sum of the left and right nostril scores evaluated through nasal endoscopy, with a total score range of 0 to 8. NPS is based on polyp grading, with a score of 0-4 based on polyp grading.
Time frame: Baseline up to thirty six weeks
Nasal congestion score (NCS)
NCS is determined by the subjects based on the severity of the nasal congestion in the past 24 hours. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.
Time frame: Baseline up to thirty six weeks
Anosmia score
Anosmia Score is evaluated by subjects based on their severity of Anosmia on the day. This score uses a 0-3 classification scale, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms.
Time frame: Baseline up to thirty six weeks
Total symptom score (TSS)
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Jingzhou Central Hospital
Jingzhou, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital Of Dalian university
Dalian, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
The Afiliated Hospital Of QINGDAO University
Qingdao, Shandong, China
...and 6 more locations
TSS is the sum of nasal congestion, anosmia, and rhinorrhea (the average of anterior and posterior rhinorrhea), with a score range of 0-9 points. The severity is evaluated by the subject and recorded on the subject diary record card.
Time frame: Baseline up to thirty six weeks
Visual analogue scale (VAS) for sinusitis
VAS for sinusitis is a questionnaire that subjective evaluation of the overall severity of sinusitis by subjects, with a score range of 0-10 points. The higher the score, the greater the impact of sinusitis on the quality of life of the subjects.
Time frame: Baseline up to thirty six weeks
Lund Mackay (LMK) score
The LMK score is based on the results of sinus Computed Tomography (CT) scans. Evaluated by researchers, divided into left and right sinus systems, with 0-12 points per side and a total score of 0-24 points.
Time frame: Baseline up to twenty eight weeks
Immunogenicity-anti-drug antibody
Incidence and their titers of Anti-drug antibody (ADA).
Time frame: 1 hour on day 1 before administration, day 197, day 253 during withdrawal
Immunogenicity-neutralizing antibody
Incidence of neutralizing antibody (Nab).
Time frame: 1 hour on day 1 before administration, day 197, day 253 during withdrawal