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

Обзор

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.

Вмешательства

• Биопрепарат Stapokibart
  Stapokibart subcutaneously every two weeks
• Препарат Mometasone Furoate Nasal Spray (MFNS)
  mometasone furoate nasal spray 200 μg once daily

Первичные конечные точки

• Nasal Polyps Score (NPS) [Срок оценки: week 16]
• Nasal Congestion Score (NCS) [Срок оценки: week 16]

Вторичные конечные точки (12)

• Nasal Polyp Score (NPS) [Срок оценки: Week 2，4，8，12，20，24，28，32，36，40]
• Nasal Congestion Score (NCS) [Срок оценки: Week 2，4，8，12，20，24，28，32，36，40]
• sino-nasal outcome test-22 (SNOT-22) [Срок оценки: Week 2，4，8，12，20，24，28，32，36，40]
• nasal total symptom score (TSS) [Срок оценки: Week 2，4，8，12，20，24，28，32，36，40]
• Asthma Control Questionnaire (ACQ-6) [Срок оценки: Week 2，4，8，12，20，24，28，32，36，40]
• Lund-Mackay CT score [Срок оценки: week 16]
• Pulmonary function test [Срок оценки: week 16]
• Change of NPS [Срок оценки: Week 2，4，8，12，16]
• Change of NCS [Срок оценки: Week 2，4，8，12，16]
• Pharmacodynamics [Срок оценки: Week 4，8，12，16，20，24，28，32，36，40]
• Pharmacodynamics [Срок оценки: week 16]
• The change of biomarkers [Срок оценки: Week 8，16，24，32，40]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tongren Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06801353 · TR-Biological treatment of NP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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