Dupilumab in CRSsNP
2期
已完成
NCT04678856
| 适应症 | Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder |
|---|
| 分期 | 2期 |
|---|
| 申办方 | Sanofi |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 71 人 |
|---|
| 干预（药物） | Dupilumab SAR231893 |
|---|
| 开始日期 | 2020年12月2日 |
|---|
| 完成日期 | 2023年11月14日 |
|---|
| 结果公布日 | 2024年12月18日 |
|---|
摘要
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 |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。