Menu
Not yet recruiting NCT06801353

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

Phase IV Interventional Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Biological Therapy Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stapokibart, Mometasone Furoate Nasal Spray (MFNS).
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Biological Therapy, Biomarkers. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Biological Stapokibart
    Stapokibart subcutaneously every two weeks
  • Drug Mometasone Furoate Nasal Spray (MFNS)
    mometasone furoate nasal spray 200 μg once daily

Primary outcome measures

  • Nasal Polyps Score (NPS) [Time frame: week 16]
  • Nasal Congestion Score (NCS) [Time frame: week 16]
Secondary outcome measures (12)
  • Nasal Polyp Score (NPS) [Time frame: Week 2，4，8，12，20，24，28，32，36，40]
  • Nasal Congestion Score (NCS) [Time frame: Week 2，4，8，12，20，24，28，32，36，40]
  • sino-nasal outcome test-22 (SNOT-22) [Time frame: Week 2，4，8，12，20，24，28，32，36，40]
  • nasal total symptom score (TSS) [Time frame: Week 2，4，8，12，20，24，28，32，36，40]
  • Asthma Control Questionnaire (ACQ-6) [Time frame: Week 2，4，8，12，20，24，28，32，36，40]
  • Lund-Mackay CT score [Time frame: week 16]
  • Pulmonary function test [Time frame: week 16]
  • Change of NPS [Time frame: Week 2，4，8，12，16]
  • Change of NCS [Time frame: Week 2，4，8，12，16]
  • Pharmacodynamics [Time frame: Week 4，8，12，16，20，24，28，32，36，40]
  • Pharmacodynamics [Time frame: week 16]
  • The change of biomarkers [Time frame: Week 8，16，24，32，40]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.
  • Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening.
  • Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening.
  • Good adherence.

Exclusion criteria

  • 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.
  • Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening/run-in period.
  • Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components.
  • Concomitant with other poorly controlled serious diseases or recurrent chronic diseases.
  • Women who are pregnant, breastfeeding, or planning either during the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tongren Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06801353 · TR-Biological treatment of NP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗