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

NCT06801353 | Not Yet Recruiting Phase 4

• 1 other identifier: TR-Biological treatment of NP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); Biological Therapy; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Nasal Polyp Score (NPS)

  Week 2，4，8，12，20，24，28，32，36，40

• Nasal Congestion Score (NCS)

  Week 2，4，8，12，20，24，28，32，36，40

• sino-nasal outcome test-22 (SNOT-22)

  Week 2，4，8，12，20，24，28，32，36，40

• nasal total symptom score (TSS)

  Week 2，4，8，12，20，24，28，32，36，40

• Asthma Control Questionnaire (ACQ-6)

  Week 2，4，8，12，20，24，28，32，36，40

Study Arms (1)

therapy group

EXPERIMENTAL

Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily

Biological: Stapokibart; Drug: Mometasone Furoate Nasal Spray (MFNS)

Interventions

Stapokibart BIOLOGICAL

Stapokibart subcutaneously every two weeks

therapy group

Mometasone Furoate Nasal Spray (MFNS) DRUG

mometasone furoate nasal spray 200 μg once daily

therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Central Study Contacts

Chengshuo Wang

CONTACT

+86-13911623569; wangcs830@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 30, 2025
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)