Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
- Registration Number
- NCT04140695
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral Capsule Tradipitant Tradipitant Oral Capsule
- Primary Outcome Measures
Name Time Method Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 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".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanda Investigational Site
🇺🇸Spokane, Washington, United States