A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tongren Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years old.
With bilateral chronic rhinosinusitis with nasal polyposis.
Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.
Nasal congestion score ≥2 at baseline.
Disqualifiers
Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives [whichever is longer] before baseline).
Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).
Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.
Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.
Trial design
Design model
Single group
Treatments tested in this trial
Stapokibart
Biological/VaccineStapokibart subcutaneously every two weeks
Mometasone Furoate Nasal Spray (MFNS)
Drugmometasone furoate nasal spray 200 μg once daily
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: therapy groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 162
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 16Secondary outcomes
1
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 2，4，8，12，20，24，28，32，36，402
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 2，4，8，12，20，24，28，32，36，403
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 2，4，8，12，20，24，28，32，36，404
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 2，4，8，12，20，24，28，32，36，40Sponsors and contacts
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Source ClinicalTrials.gov
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