Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Stapokibart subcutaneously every two weeks
mometasone furoate nasal spray 200 μg once daily
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Nasal Polyps Score (NPS)
NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Time frame: week 16
Nasal Congestion Score (NCS)
Change from baseline in the Nasal Congestion Score (NCS) at week 16. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Time frame: week 16
Nasal Polyp Score (NPS)
Changes from baseline in nasal polyp score (NPS) at each evaluation time point. NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Time frame: Week 2，4，8，12，20，24，28，32，36，40
Nasal Congestion Score (NCS)
Changes from baseline in nasal congestion score (NCS) at each evaluation time point. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Time frame: Week 2，4，8，12，20，24，28，32，36，40
sino-nasal outcome test-22 (SNOT-22)
Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point. The SNOT-22 score is the sum of the scores of 22 items, ranging from 0 to 110 (higher scores indicate worse outcomes).
Time frame: Week 2，4，8，12，20，24，28，32，36，40
nasal total symptom score (TSS)
Changes from baseline in nasal total symptom score (TSS) at each evaluation timepoint. The evaluation content of TSS includes three aspects: nasal congestion, loss of smell and running nose. Each aspect has a score of 0-3 with a total score of 0-9. The higher score indicates the more severe overall symptom.
Time frame: Week 2，4，8，12，20，24，28，32，36，40
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Asthma Control Questionnaire (ACQ-6)
Changes from baseline in Asthma Control Questionnaire (ACQ-6) at each evaluation timepoint for participants with asthma. The ACQ-6 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 according to its severity. The higher the score, the less satisfactory symptom control is.
Time frame: Week 2，4，8，12，20，24，28，32，36，40
Lund-Mackay CT score
Change from baseline in Lund-Mackay CT score evaluated by sinus computed tomography (CT) at each evaluation timepoint. The total Lund-Mackay score ranges from 0 to 24 points. The six parts of the nasal sinuses on both sides are evaluated separately. The higher the score, the more severe the CRS condition.
Time frame: week 16
Pulmonary function test
Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma.
Time frame: week 16
Change of NPS
Proportion of participants with ≥1 point improvement from baseline in NPS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NPS at each evaluation timepoint.
Time frame: Week 2，4，8，12，16
Change of NCS
Proportion of participants with ≥1 point improvement from baseline in NCS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NCS at each evaluation timepoint.
Time frame: Week 2，4，8，12，16
Pharmacodynamics
Change from baseline in serum biomarker level (eosinophil level).
Time frame: Week 4，8，12，16，20，24，28，32，36，40
Pharmacodynamics
Change from baseline of eosinophil level in nasal polyps biospy tissue.
Time frame: week 16
The change of biomarkers
Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Time frame: Week 8，16，24，32，40
Pulmonary function test
Change from baseline in forced vital capacity (FVC) at each evaluation timepoint for participants with asthma.
Time frame: week 16
Pulmonary function test
Change from baseline in mean flow with forced expiratory volume of 25% \~ 75% vital capacity (FEF25 \~ 75%) at each evaluation timepoint for participants with asthma.
Time frame: week 16