Dupilumab in CRSsNP
第2相
完了
NCT04678856
| 対象疾患 | Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder |
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| 相 | 第2相 |
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| スポンサー | Sanofi |
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| ステータス | 完了 |
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| 参加者数 | 71 名 |
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| 介入（薬剤） | Dupilumab SAR231893 |
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| 開始日 | 2020年12月2日 |
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| 完了日 | 2023年11月14日 |
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| 結果公開日 | 2024年12月18日 |
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概要
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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