Clinical trial NCT06801353: A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps
Official title: A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Biological Therapy
Biomarkers
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Nasal Polyps Score (NPS)
timeFrame: week 16
measure: Nasal Congestion Score (NCS)
timeFrame: week 16
Secondary outcomes:
measure: Nasal Polyp Score (NPS)
timeFrame: Week 2，4，8，12，20，24，28，32，36，40
measure: Nasal Congestion Score (NCS)
timeFrame: Week 2，4，8，12，20，24，28，32，36，40
measure: sino-nasal outcome test-22 (SNOT-22)
timeFrame: Week 2，4，8，12，20，24，28，32，36，40
measure: nasal total symptom score (TSS)
timeFrame: Week 2，4，8，12，20，24，28，32，36，40
measure: Asthma Control Questionnaire (ACQ-6)
timeFrame: Week 2，4，8，12，20，24，28，32，36，40
measure: Lund-Mackay CT score
timeFrame: week 16
measure: Pulmonary function test
timeFrame: week 16
measure: Change of NPS
timeFrame: Week 2，4，8，12，16
measure: Change of NCS
timeFrame: Week 2，4，8，12，16
measure: Pharmacodynamics
timeFrame: Week 4，8，12，16，20，24，28，32，36，40
measure: Pharmacodynamics
timeFrame: week 16
measure: The change of biomarkers
timeFrame: Week 8，16，24，32，40
measure: Pulmonary function test
timeFrame: week 16
measure: Pulmonary function test
timeFrame: week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
Study officials:
References: