Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps

Официальное название

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps

Обзор

The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)

Вмешательства

• Препарат SHR-1905 Injection
  SHR-1905 Injection
• Препарат SHR-1905 Placebo Injection
  SHR-1905 Placebo Injection

Первичные конечные точки

• Nasal polyp scores (NPS) [Срок оценки: Baseline to Week 24]
• Nasal Congestion Scores (NCS) [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (5)

• Lund Mackay score (LMK) from baseline on sinus CT scan [Срок оценки: Baseline to Week 24]
• Loss of smell [Срок оценки: Baseline to Week 24]
• Proportion of subjects with NPS≤1 point per nostril [Срок оценки: Baseline to Week 24]
• Sino-nasal outcome test-22 (SNOT-22) scores [Срок оценки: Baseline to Week 24]
• Total symptoms score (TSS) [Срок оценки: Baseline to Week 24]

Критерии участия

Критерии включения

• Weight ≥40kg
• Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
• Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
• NCS ≥2 at screening and baseline.
• SNOT-22≥30 at screening period and baseline.
• Recorded persistent NP symptoms for over 4 weeks prior to screening.
• Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization.
• NP surgery in the past and/or SCS use within 1 years before screening(or with contraindications/ intolerances).

Критерии исключения

• Any comorbidities that may affect the efficacy evaluation of nasal polyps.
• Any comorbidities except for asthma that may affect blood EOS levels.
• Concomitant with immunodeficiency.
• Concomitant with contraindications or not suitable for nasal endoscopy.
• Uncontrolled hypertension and/or uncontrolled diabetes.
• Concomitant with infection within 4 weeks prior to randomization.
• Uncontrolled epistaxis within 4 weeks prior to randomization.
• Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
• Parasitic infection within 6 months before randomization.
• Sinus or intranasal surgery within 6 months prior to screening, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
• Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
• Abnormalities of laboratory tests at screening or baseline.
• Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
• Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
• FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
• Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
• SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
• Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
• Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
• Allergen immunotherapy within 8 weeks before randomization.
• Smoking at screening, or smoking cessation less than 6 months at screening.
• Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization.

Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye & Ent Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07132827 · SHR-1905-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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