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

NCT ID: NCT06801353

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapy group

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

Group Type: EXPERIMENTAL

Stapokibart

Intervention Type: BIOLOGICAL

Stapokibart subcutaneously every two weeks

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

mometasone furoate nasal spray 200 μg once daily

Interventions

Stapokibart

Stapokibart subcutaneously every two weeks

Intervention Type: BIOLOGICAL

Mometasone Furoate Nasal Spray (MFNS)

mometasone furoate nasal spray 200 μg once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Chengshuo Wang

Role: CONTACT

wangcs830@126.com

+86-13911623569

Facility Contacts

Chengshuo Wang

Role: primary

wangcs830@126.com

+86-13911623569

Other Identifiers

TR-Biological treatment of NP

Identifier Type: -

Identifier Source: org_study_id