Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older (MSRD-100)
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of MSRD-100 in Subjects >=3 Months of Age With Atopic Dermatitis
研究概览
详细说明
This is a 4-week efficacy, safety and tolerability study of MSRD-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area.
The study will consist of up to 4 visits which includes Screening - Visit 1 (Screening), Baseline - Visit 2 , Visit 3 (Day 14), and an End of Treatment/Final Study Visit - Visit 4 (Day 28).
Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites.
研究类型
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Subjects who are male or female, ≥3 months of age on the date of Baseline Visit.
- Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for atopic dermatitis.
- Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline.
- Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants).
- Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected.
Key Exclusion Criteria:
- Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
- Concurrent conditions and history of other diseases.
- Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study.
- Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:MSRD-100
MSRD-100 is a topical gel with an active ingredient in a vehicle.
Excipients are purified water, propylene glycol, polysorbate 20, benzyl alcohol, edetate disodium, diethylene glycol monoethyl ether and hydroxyethyl cellulose.
Application is twice daily for 28 days.
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MSRD-100 是一种外用凝胶。
其他名称:
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安慰剂比较:Placebo Comparator
The vehicle is a topical gel and contains excipients of the formulation: purified water, propylene glycol, polysorbate 20, benzyl alcohol, edetate disodium, diethylene glycol monoethyl ether and hydroxyethyl cellulose.
It does not contain the active ingredient MSRD-100.
Application is twice daily for 28 days.
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Vehicle is a topical gel without the active ingredients in MSRD-100
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
比较 MSRD-100 和载体组中治疗成功的受试者比例
大体时间:访问 4(第 28 天)
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治疗成功定义为研究者整体评估 (IGA) 评分清晰或几乎清晰,IGA 评分较基线至少改善 2 级,且基线时出现的任何体征均未恶化。 主要终点是以下各项的综合:(1) IGA 评分清除或几乎清除,以及受试者的 IGA 至少有两点改善,加上 (2) 基线时出现的任何体征没有恶化。 |
访问 4(第 28 天)
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次要结果测量
结果测量 |
大体时间 |
---|---|
比较第 4 次访问时 MSRD-100 和车辆之间 IGA 得分为 0 或 1 的受试者比例
大体时间:访问 4(第 28 天)
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访问 4(第 28 天)
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合作者和调查者
调查人员
- 研究主任:Michael Kuligowski, MD, PhD, MBA、Study Director
研究记录日期
研究主要日期
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
MSRD-100的临床试验
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Sumitomo Pharma America, Inc.BehaVR LLC完全的
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Boston Scientific CorporationGuidant Corporation完全的心脏衰竭 | 心室颤动 | 室性心动过速 | 心室扑动德国, 西班牙, 瑞士, 中国, 奥地利, 比利时, 法国, 希腊, 拉脱维亚, 荷兰, 斯洛伐克