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
Qualifiers
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
Treatments tested in this trial
- Stapokibart
- Mometasone Furoate Nasal Spray (MFNS)
Treatment groups
90 Participants
are divided into 1 treatment groupLocations
1Beijing Tongren Hospital, Capital Medical University100000, BeijingBeijing Municipality, China
Sponsors and collaborators
Beijing Tongren Hospital
Lead sponsor
Source ClinicalTrials.gov