Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)

Study Overview
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Brief Summary
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This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Tradipitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant<br>Oral Capsule | Drug: Tradipitant<br>* BID<br>|
| Placebo Comparator: Placebo<br>Oral Capsule | Drug: Placebo<br>* BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of worst itch in atopic dermatitis | As rated by the Worst Itch-Numerical Rating Scale (WI-NRS). Patient responses will be measured on a scale from 0 (no itch) to 10 (worst itch imaginable) over a period of 8 weeks. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of disease severity in atopic dermatitis | As rated by SCORing Atopic Dermatitis (SCORAD) index. Severity of atopic dermatitis will be measured on a scale from 0 (absent) to 103 (severe) over a period of 8 weeks. | 8 weeks | 
| Improvement of disease severity in atopic dermatitis | As rated by the Eczema Area and Severity Index (EASI). Severity of atopic dermatitis will be measured on a scale from 0 (absent) to 72 (severe) over a period of 8 weeks. | 8 weeks | 
| Improvement of disease severity in atopic dermatitis | As rated by the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD). Severity of atopic dermatitis will be measured on a scale from 0 (absent) to 4 (severe) over a period of 8 weeks. | 8 weeks | 
| Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pruritus, Eczema