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

Capital Medical University

Status and phase: Not yet enrolling; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06801353

TR-Biological treatment of NP

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

therapy group

Experimental group

Description:

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

Treatment:

Drug: Mometasone Furoate Nasal Spray (MFNS)

Biological: Stapokibart