Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Biological Therapy, Biomarkers
Conditions
Brief summary
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.
Interventions
BIOLOGICALStapokibart
Stapokibart subcutaneously every two weeks
mometasone furoate nasal spray 200 μg once daily
Sponsors
Beijing Tongren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years old. 2. With bilateral chronic rhinosinusitis with nasal polyposis. 3. Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline. 4. Nasal congestion score ≥2 at baseline. 5. Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and/or have contraindications or intolerance to SCS treatment, and/or received surgical for nasal polyps more than 6 months before screening. 6. Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening. 7. Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening. 8. Good adherence.
Exclusion criteria
1. Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives \[whichever is longer\] before baseline). 2. Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer). 3. Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline. 4. Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score. 5. Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening/run-in period. 6. Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components. 7. Concomitant with other poorly controlled serious diseases or recurrent chronic diseases. 8. Women who are pregnant, breastfeeding, or planning either during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Polyps Score (NPS) | week 16 | NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome. |
| Nasal Congestion Score (NCS) | week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sino-nasal outcome test-22 (SNOT-22) | Week 2，4，8，12，20，24，28，32，36，40 | 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). |
| nasal total symptom score (TSS) | Week 2，4，8，12，20，24，28，32，36，40 | 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. |
| Asthma Control Questionnaire (ACQ-6) | Week 2，4，8，12，20，24，28，32，36，40 | 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. |
| Lund-Mackay CT score | week 16 | 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. |
| Nasal Polyp Score (NPS) | Week 2，4，8，12，20，24，28，32，36，40 | 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. |
| Change of NPS | Week 2，4，8，12，16 | 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. |
| Change of NCS | Week 2，4，8，12，16 | 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. |
| Pharmacodynamics | Week 4，8，12，16，20，24，28，32，36，40 | Change from baseline in serum biomarker level (eosinophil level). |
| The change of biomarkers | Week 8，16，24，32，40 | Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes. |
| Pulmonary function test | week 16 | Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma. |
| Nasal Congestion Score (NCS) | Week 2，4，8，12，20，24，28，32，36，40 | 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. |
Countries
China
Contacts
Primary ContactChengshuo Wang
Outcome results
None listed