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Clinical Trials in China / NCT06801353
Starting soon Phase 4

A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps

NCT06801353 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tongren Hospital
Phase
Phase 4
Started
2025-02-01
Last updated
2025-02-06

Condition(s) studied

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)Biological TherapyBiomarkers

Investigational drug(s) / intervention(s)

StapokibartMometasone Furoate Nasal Spray (MFNS)

Stapokibart: Stapokibart subcutaneously every two weeks

Mometasone Furoate Nasal Spray (MFNS): mometasone furoate nasal spray 200 μg once daily

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801353 on ClinicalTrials.gov ↗ ← All trials in China