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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tradipitant
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Chronic Pruritus, Eczema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tradipitant

Placebo

Arm Description

Oral Capsule

Oral Capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)

Full Information

First Posted
October 24, 2019
Last Updated
April 28, 2022
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04140695
Brief Title
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
Acronym
EPIONE2
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Chronic Pruritus, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tradipitant
Arm Type
Experimental
Arm Description
Oral Capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Tradipitant
Intervention Description
BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BID
Primary Outcome Measure Information:
Title
Reduction of worst itch in atopic dermatitis
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improvement of disease severity in atopic dermatitis
Description
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.
Time Frame
8 weeks
Title
Improvement of disease severity in atopic dermatitis
Description
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.
Time Frame
8 weeks
Title
Improvement of disease severity in atopic dermatitis
Description
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.
Time Frame
8 weeks
Title
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 60 days
Facility Information:
Facility Name
Vanda Investigational Site
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Vanda Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Vanda Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Vanda Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Vanda Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Vanda Investigational Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Vanda Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Vanda Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Vanda Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Vanda Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Vanda Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Vanda Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Vanda Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Vanda Investigational Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Vanda Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Vanda Investigational Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Vanda Investigational Site
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Vanda Investigational Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Vanda Investigational Site
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Vanda Investigational Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Vanda Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Vanda Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Vanda Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Vanda Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Vanda Investigational Site
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
Vanda Investigational Site
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Vanda Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States
Facility Name
Vanda Investigational Site
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Vanda Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Vanda Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vanda Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Vanda Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Vanda Investigational Site
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Vanda Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Vanda Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Vanda Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Vanda Investigational Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Vanda Investigational Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Vanda Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Vanda Investigational Site
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
Country
United States
Facility Name
Vanda Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Vanda Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Vanda Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Links:
URL
http://advandastudy.com
Description
Study Webpage

Learn more about this trial

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

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