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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapy group | Experimental | Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapokibart | Biological | Stapokibart subcutaneously every two weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Polyps Score (NPS) | NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome. | 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. | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2，4，8，12，20，24，28，32，36，40 |
| Nasal Congestion Score (NCS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengshuo Wang | Contact | +86-13911623569 | wangcs830@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
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| Mometasone Furoate Nasal Spray (MFNS) |
| Drug |
mometasone furoate nasal spray 200 μg once daily |
|
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. |
| 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). | 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. | Week 2，4，8，12，20，24，28，32，36，40 |
| 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. | 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. | week 16 |
| Pulmonary function test | Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma. | 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. | 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. | Week 2，4，8，12，16 |
| Pharmacodynamics | Change from baseline in serum biomarker level (eosinophil level). | Week 4，8，12，16，20，24，28，32，36，40 |
| Pharmacodynamics | Change from baseline of eosinophil level in nasal polyps biospy tissue. | week 16 |
| The change of biomarkers | Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes. | 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. | 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. | week 16 |