A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.
Secondary Objectives:
To evaluate effect of dupilumab with regards to:
- symptoms of sinusitis,
- sinus computed tomography (CT) scan,
- NPS in the sub-group of participants with co-morbid asthma,
- Safety and tolerability.
详细描述
Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks.
To ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dupilumab 300 mg QW
Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
干预措施: Mometasone furoate nasal spray (Drug)
Placebo
Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS).
干预措施: Placebo (for dupilumab) (Drug)
Placebo
Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS).
干预措施: Mometasone furoate nasal spray (Drug)
Dupilumab 300 mg QW
Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16
时间窗: Baseline, Week 16
NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps.
次要结局
- Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease(Baseline, Week 16)
- Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16(Baseline, Week 16)
- Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16(Baseline, Week 16)
- Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma(Baseline, Week 16)
- Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score(Baseline, Week 16)
- Time to First Response in NPS: Kaplan-Meier Estimate at Week 16(Baseline to Week 16)
- Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16(Baseline, Week 16)
- Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16(Baseline, Week 16)
- Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16(Baseline, Week 16)