Clinical trial NCT03568331: Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)
Official title: A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Chronic Pruritus
Eczema
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of Worst Itch in Atopic Dermatitis
timeFrame: 8 weeks
Secondary outcomes:
measure: Improvement of Disease Severity in Atopic Dermatitis
timeFrame: 8 weeks
measure: Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Tempe
country: United States
facility: Vanda Investigational Site
state: Arizona
city: Encino
country: United States
facility: Vanda Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Vanda Investigational Site
state: California
city: Fremont
country: United States
facility: Vanda Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Vanda Investigational Site
state: California
city: Lomita
country: United States
facility: Vanda Investigational Site
state: California
city: Long Beach
country: United States
facility: Vanda Investigational Site
state: California
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
city: Denver
country: United States
facility: Vanda Investigational Site
state: Colorado
city: Aventura
country: United States
facility: Vanda Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Vanda Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Vanda Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Vanda Investigational Site
state: Florida
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Miramar
country: United States
facility: Vanda Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Vanda Investigational Site
state: Florida
city: South Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Tampa
country: United States
facility: Vanda Investigational Site
state: Florida
city: Savannah
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Boise
country: United States
facility: Vanda Investigational Site
state: Idaho
city: Normal
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Plainfield
country: United States
facility: Vanda Investigational Site
state: Indiana
city: Crowley
country: United States
facility: Vanda Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Towson
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Beverly
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Brighton
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Vanda Investigational Site
state: Michigan
city: Saint Joseph
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Vanda Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Verona
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Vanda Investigational Site
state: New York
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: Charlotte
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Vanda Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Vanda Investigational Site
state: Pennsylvania
city: Johnston
country: United States
facility: Vanda Investigational Site
state: Rhode Island
city: North Charleston
country: United States
facility: Vanda Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Vanda Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Vanda Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: Vanda Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Vanda Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Vanda Investigational Site
state: Texas
city: West Jordan
country: United States
facility: Vanda Investigational Site
state: Utah
city: South Burlington
country: United States
facility: Vanda Investigational Site
state: Vermont
city: Newport News
country: United States
facility: Vanda Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Vanda Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Vanda Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Vanda Investigational Site
state: Washington
Study officials:
References: