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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biomarkers; Biological Therapy; Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
• Intervention / Treatment: Biological: Stapokibart; Drug: Mometasone Furoate Nasal Spray (MFNS)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: chengshuo wang; Phone Number: +86-13911623569; Email: wangcs830@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Tongren Hospital, Capital Medical University
      • Contact: chengshuo wang; Phone Number: +86-13911623569; Email: wangcs830@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: therapy group; Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily	Biological: Stapokibart; Stapokibart subcutaneously every two weeks; Drug: Mometasone Furoate Nasal Spray (MFNS); mometasone furoate nasal spray 200 μg once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Polyp Score (NPS)	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.	Week 2，4，8，12，20，24，28，32，36，40
Nasal Congestion Score (NCS)	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.	Week 2，4，8，12，20，24，28，32，36，40
sino-nasal outcome test-22 (SNOT-22)	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).	Week 2，4，8，12，20，24，28，32，36，40
nasal total symptom score (TSS)	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.	Week 2，4，8，12，20，24，28，32，36，40
Asthma Control Questionnaire (ACQ-6)	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.	Week 2，4，8，12，20，24，28，32，36，40
Lund-Mackay CT score	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.	week 16
Pulmonary function test	Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma.	week 16
Change of NPS	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.	Week 2，4，8，12，16
Change of NCS	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.	Week 2，4，8，12，16
Pharmacodynamics	Change from baseline in serum biomarker level (eosinophil level).	Week 4，8，12，16，20，24，28，32，36，40
Pharmacodynamics	Change from baseline of eosinophil level in nasal polyps biospy tissue.	week 16
The change of biomarkers	Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.	Week 8，16，24，32，40
Pulmonary function test	Change from baseline in forced vital capacity (FVC) at each evaluation timepoint for participants with asthma.	week 16
Pulmonary function test	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.	week 16

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Rhinosinusitis; Polyps; Nasal Polyps; Sinusitis; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: TR-Biological treatment of NP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No