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NCT03568331 Clinical Trial

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

Atopic Dermatitis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03568331
Other study ID # VP-VLY-686-3101
Secondary ID EPIONE
Status Completed
Phase Phase 3
First received
Last updated
Start date July 9, 2018
Est. completion date December 27, 2019

Study information
Verified date April 2024
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Recruitment information / eligibility
Status Completed
Enrollment 375
Est. completion date December 27, 2019
Est. primary completion date December 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 8 weeks

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tradipitant
Oral Capsule
• Placebo
Oral Capsule

Locations
Country Name City State
United States Vanda Investigational Site Aventura Florida
United States Vanda Investigational Site Berlin New Jersey
United States Vanda Investigational Site Beverly Massachusetts
United States Vanda Investigational Site Birmingham Alabama
United States Vanda Investigational Site Birmingham Alabama
United States Vanda Investigational Site Boise Idaho
United States Vanda Investigational Site Brighton Massachusetts
United States Vanda Investigational Site Brooklyn New York
United States Vanda Investigational Site Charlotte North Carolina
United States Vanda Investigational Site Chattanooga Tennessee
United States Vanda Investigational Site Cincinnati Ohio
United States Vanda Investigational Site Clearwater Florida
United States Vanda Investigational Site Crowley Louisiana
United States Vanda Investigational Site Dallas Texas
United States Vanda Investigational Site Dayton Ohio
United States Vanda Investigational Site Denver Colorado
United States Vanda Investigational Site Encino California
United States Vanda Investigational Site Fort Gratiot Michigan
United States Vanda Investigational Site Fort Lauderdale Florida
United States Vanda Investigational Site Fountain Valley California
United States Vanda Investigational Site Fremont California
United States Vanda Investigational Site Hialeah Florida
United States Vanda Investigational Site High Point North Carolina
United States Vanda Investigational Site Johnston Rhode Island
United States Vanda Investigational Site Laguna Hills California
United States Vanda Investigational Site Las Vegas Nevada
United States Vanda Investigational Site Las Vegas Nevada
United States Vanda Investigational Site Lomita California
United States Vanda Investigational Site Long Beach California
United States Vanda Investigational Site Los Angeles California
United States Vanda Investigational Site Los Angeles California
United States Vanda Investigational Site Miami Florida
United States Vanda Investigational Site Miami Florida
United States Vanda Investigational Site Miramar Florida
United States Vanda Investigational Site Nashville Tennessee
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site Newport News Virginia
United States Vanda Investigational Site Norfolk Virginia
United States Vanda Investigational Site Normal Illinois
United States Vanda Investigational Site North Charleston South Carolina
United States Vanda Investigational Site Oklahoma City Oklahoma
United States Vanda Investigational Site Omaha Nebraska
United States Vanda Investigational Site Ormond Beach Florida
United States Vanda Investigational Site Pflugerville Texas
United States Vanda Investigational Site Philadelphia Pennsylvania
United States Vanda Investigational Site Pittsburgh Pennsylvania
United States Vanda Investigational Site Plainfield Indiana
United States Vanda Investigational Site Richmond Virginia
United States Vanda Investigational Site Rockville Maryland
United States Vanda Investigational Site Saint Joseph Missouri
United States Vanda Investigational Site Saint Louis Missouri
United States Vanda Investigational Site San Antonio Texas
United States Vanda Investigational Site San Antonio Texas
United States Vanda Investigational Site San Diego California
United States Vanda Investigational Site Santa Monica California
United States Vanda Investigational Site Savannah Georgia
United States Vanda Investigational Site Skokie Illinois
United States Vanda Investigational Site South Burlington Vermont
United States Vanda Investigational Site South Miami Florida
United States Vanda Investigational Site Spartanburg South Carolina
United States Vanda Investigational Site Spokane Washington
United States Vanda Investigational Site Tampa Florida
United States Vanda Investigational Site Tempe Arizona
United States Vanda Investigational Site Towson Maryland
United States Vanda Investigational Site Tulsa Oklahoma
United States Vanda Investigational Site Verona New Jersey
United States Vanda Investigational Site West Jordan Utah
United States Vanda Investigational Site Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of Worst Itch in Atopic Dermatitis Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours [0=No Itch, 10=Worst Itch Imaginable]. 8 weeks
Secondary Improvement of Disease Severity in Atopic Dermatitis Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease). 8 weeks
Secondary Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting. 8 weeks
See also
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Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

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