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

Phase 4

Not yet recruiting

• Conditions: Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); Biological Therapy; Biomarkers
• Interventions: Biological: Stapokibart; Drug: Mometasone Furoate Nasal Spray (MFNS)

• Registration Number: NCT06801353
• Lead Sponsor: Beijing Tongren Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-30
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy group	Mometasone Furoate Nasal Spray (MFNS)	Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily
therapy group	Stapokibart	Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily

Primary Outcome Measures

Name	Time	Method
Nasal Polyps Score (NPS)	week 16	NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Nasal Congestion Score (NCS)	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 Outcome Measures

Name	Time	Method
Nasal Polyp Score (NPS)	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.
Nasal Congestion Score (NCS)	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.
sino-nasal outcome test-22 (SNOT-22)	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).
nasal total symptom score (TSS)	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.
Asthma Control Questionnaire (ACQ-6)	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.
Lund-Mackay CT score	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.
Pulmonary function test	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.
Change of NPS	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.
Change of NCS	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.
Pharmacodynamics	week 16	Change from baseline of eosinophil level in nasal polyps biospy tissue.
The change of biomarkers	Week 8，16，24，32，40	Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.

Trial Locations

Locations (1)

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China