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NCT Number: NCT06801353

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

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Biological Therapy Biomarkers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location contact

Chengshuo Wang

CONTACT

[email protected]

+86-13911623569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapokibart

Biological

Stapokibart subcutaneously every two weeks

Mometasone Furoate Nasal Spray (MFNS)

Drug

mometasone furoate nasal spray 200 μg once daily

Primary outcomes

  1. Nasal Polyps Score (NPS)

    Time frame: week 16

    NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.

  2. Nasal Congestion Score (NCS)

    Time frame: week 16

    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.

Secondary outcomes

  1. Nasal Polyp Score (NPS)

    Time frame: Week 2，4，8，12，20，24，28，32，36，40

    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.

  2. Nasal Congestion Score (NCS)

    Time frame: Week 2，4，8，12，20，24，28，32，36，40

    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.

  3. sino-nasal outcome test-22 (SNOT-22)

    Time frame: Week 2，4，8，12，20，24，28，32，36，40

    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).

  4. nasal total symptom score (TSS)

    Time frame: Week 2，4，8，12，20，24，28，32，36，40

    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.

  5. Asthma Control Questionnaire (ACQ-6)

    Time frame: Week 2，4，8，12，20，24，28，32，36，40

    Changes from baseline in Asthma Control Questionnaire (ACQ-6) at each evaluation timepoint for participants with asthma. The ACQ-6 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 according to its severity. The higher the score, the less satisfactory symptom control is.

  6. Lund-Mackay CT score

    Time frame: week 16

    Change from baseline in Lund-Mackay CT score evaluated by sinus computed tomography (CT) at each evaluation timepoint. The total Lund-Mackay score ranges from 0 to 24 points. The six parts of the nasal sinuses on both sides are evaluated separately. The higher the score, the more severe the CRS condition.

  7. Pulmonary function test

    Time frame: week 16

    Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma.

  8. Change of NPS

    Time frame: Week 2，4，8，12，16

    Proportion of participants with ≥1 point improvement from baseline in NPS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NPS at each evaluation timepoint.

  9. Change of NCS

    Time frame: Week 2，4，8，12，16

    Proportion of participants with ≥1 point improvement from baseline in NCS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NCS at each evaluation timepoint.

  10. Pharmacodynamics

    Time frame: Week 4，8，12，16，20，24，28，32，36，40

    Change from baseline in serum biomarker level (eosinophil level).

  11. Pharmacodynamics

    Time frame: week 16

    Change from baseline of eosinophil level in nasal polyps biospy tissue.

  12. The change of biomarkers

    Time frame: Week 8，16，24，32，40

    Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.

  13. Pulmonary function test

    Time frame: week 16

    Change from baseline in forced vital capacity (FVC) at each evaluation timepoint for participants with asthma.

  14. Pulmonary function test

    Time frame: week 16

    Change from baseline in mean flow with forced expiratory volume of 25% ~ 75% vital capacity (FEF25 ~ 75%) at each evaluation timepoint for participants with asthma.

Study contacts

Contact information is provided by the study sponsor or research team.

Chengshuo Wang

CONTACT

[email protected]

+86-13911623569

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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