A Randomized, 52-Week Treatment Double-Blind, Placebo-Controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Efficacy of Dupilumab
研究概览
简要总结
Background:
Allergic fungal rhinosinusitis (AFRS) is a severe type of sinus infection. People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing. Surgery can remove the polyps, but they often grow back. Researchers want to test an approved drug they believe may help people with AFRS.
Objective:
To test a drug (Dupilumab) in people with AFRS.
Eligibility:
People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps.
Design:
Participants will have several tests before their surgery. They will have imaging scans of their sinuses. They will have an endoscopic exam: A tube with a camera and a light will be inserted into their sinuses. They may give blood and mucus samples. They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery.
Excess nasal tissue removed during the surgery will be collected for research. Then they will begin treatment with the study drug.
Dupilumab is injected under the skin. Some participants will receive the study drug. Some will receive a placebo injections. The placebo injections are just like the study drug but contain no medicine. Participants will not know which injections they are getting.
All participants will administer the injections to themselves at home. They will do this every 2 weeks for 1 year after the surgery. They will have a clinic visit 16 weeks after surgery.
Participants will have follow-up for 12 weeks after treatment ends.
详细描述
Study Description:
Multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of dupilumab to placebo in allergic fungal rhinosinusitis (AFRS) subjects after sinus surgery on a background treatment with intranasal corticosteroid spray.
Study periods:
The clinical trial consists of 4 periods:
-Run-in period (2 weeks + 4 weeks):
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 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
Arm A:
Treatment: Dupilumab 300 mg administered subcutaneously every two weeks for 52 weeks.
干预措施: Dupilumab (Drug)
Arm B:
Control: Placebo administered subcutaneously every two weeks for 52 weeks.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Efficacy of Dupilumab
时间窗: Change from baseline at 52 weeks
-Control of sinonasal inflammation.-Prevention of nasal polyp recurrence after complete sinus surgery for AFRS.-Measured by change in the modified Lund-Kennedy (mLK) score.
次要结局
- Effect of Dupilumab on Oral Corticosteroid Utilization(Change from baseline at 52 weeks)
- Secondary Objective Measures of Sinonasal Inflammation(Change from baseline at 52 weeks)
- Lower Airway Dysfunction in Participants with Asthma(Change from baseline at 52 weeks)
- Prevention of Revision Surgery for AFRS(Change from baseline at 52 weeks)
- Health-Related Quality of Life(Change from baseline at 52 weeks)
- Utilization of Rescue Medications(Change from baseline at 52 weeks)