Dupilumab in CRSsNP
Фаза 2
Завершено
NCT04678856
| Заболевание | Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder |
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| Фаза | Фаза 2 |
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| Спонсор | Sanofi |
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| Статус | Завершено |
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| Участники | 71 участн. |
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| Вмешательство | Dupilumab SAR231893 |
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| Дата начала | 2.12.2020 |
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| Дата завершения | 14.11.2023 |
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| Публикация результатов | 18.12.2024 |
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Кратко
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: * To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo * To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo * To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo * Assessment of immunogenicity to dupilumab over time compared to placebo
Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group
Baseline (Day 1) and Week 24 · Score on a scale
| Dupilumab 300 mg q2w | -6.63 ± 3.91 Score on a scale |
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