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

Launched by BEIJING TONGREN HOSPITAL · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict how well a specific biological therapy, aimed at a target called IL-4Rα, will work for people with chronic rhinosinusitis with nasal polyps (CRSwNP). This condition causes long-lasting inflammation in the nasal passages, often leading to symptoms like nasal congestion, loss of smell, and the presence of nasal polyps. The goal of the study is to create a simple, non-invasive model that can help doctors figure out which patients are likely to benefit from this therapy.

To participate in the trial, individuals must be between 18 and 75 years old and have a diagnosis of CRSwNP with a certain level of nasal polyps and congestion. They should have been using a stable dose of intranasal corticosteroids for at least 4 weeks and have experienced specific symptoms for at least 4 weeks. The trial is not currently recruiting participants, but it is important to note that individuals with certain health conditions or recent treatments may not be eligible. Participants can expect to undergo assessments to determine their suitability for the therapy and help advance research in treating CRSwNP.

Gender

ALL

Eligibility criteria

• 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.