NCT04140695终止3 期
A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
- •Diagnosed with atopic dermatitis;
- •Suffering from chronic pruritus;
- •Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
排除标准
- •Chronic pruritus due to condition other than atopic dermatitis (AD);
- •A positive test for drugs of abuse at the screening or evaluation visits;
- •Exposure to any investigational medication in the past 60 days
研究组 & 干预措施
Tradipitant
Experimental
Oral Capsule
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
Oral Capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
时间窗: 2 weeks
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)Atopic DermatitisNCT03568331Vanda Pharmaceuticals375
已完成
2 期
Tradipitant in Treatment-resistant Pruritus Associated With Atopic DermatitisAtopic DermatitisNCT02651714Vanda Pharmaceuticals168
已完成
2 期
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of GastroparesisGastroparesisNCT02970968Vanda Pharmaceuticals152
Unknown
4 期
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase InjectionHemoptysisNCT03270735Lee's Pharmaceutical Limited100
撤回
3 期
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)Refractory Status EpilepticusNCT05814523Marinus Pharmaceuticals