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

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ClinicalTrials.gov Identifier: NCT04140695
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tradipitant Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY STUDY OF THE NEUROKININ-1 RECEPTOR ANTAGONIST VLY-686 IN PATIENTS WITH ATOPIC DERMATITIS
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tradipitant
Oral Capsule
Drug: Tradipitant
BID

Placebo Comparator: Placebo
Oral Capsule
Drug: Placebo
BID




Primary Outcome Measures :
  1. Reduction of worst itch in atopic dermatitis [ Time Frame: 8 weeks ]
    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 :
  1. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    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.

  2. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    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.

  3. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    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.

  4. Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140695


Contacts
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Contact: Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com

Locations
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United States, Alabama
Vanda Investigational Site Recruiting
Birmingham, Alabama, United States, 35224
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Arizona
Vanda Investigational Site Recruiting
Tempe, Arizona, United States, 85283
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, California
Vanda Investigational Site Recruiting
Encino, California, United States, 91436
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Fountain Valley, California, United States, 92708
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Laguna Hills, California, United States, 92653
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Lomita, California, United States, 90717
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Los Angeles, California, United States, 90036
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
Vanda Investigational Site Recruiting
Los Angeles, California, United States, 90057
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
Vanda Investigational Site Recruiting
Santa Monica, California, United States, 90404
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Florida
Vanda Investigational Site Recruiting
Clearwater, Florida, United States, 33756
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Miami, Florida, United States, 33126
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Tampa, Florida, United States, 33613
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Georgia
Vanda Investigational Site Recruiting
Savannah, Georgia, United States, 31406
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Idaho
Vanda Investigational Site Recruiting
Boise, Idaho, United States, 83704
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Illinois
Vanda Investigational Site Recruiting
Chicago, Illinois, United States, 60611
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
Vanda Investigational Site Recruiting
Normal, Illinois, United States, 61761
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Skokie, Illinois, United States, 60077
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
United States, Indiana
Vanda Investigational Site Recruiting
Plainfield, Indiana, United States, 46168
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Louisiana
Vanda Investigational Site Recruiting
Crowley, Louisiana, United States, 70526
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Maryland
Vanda Investigational Site Recruiting
Towson, Maryland, United States, 21204
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Michigan
Vanda Investigational Site Recruiting
Fort Gratiot, Michigan, United States, 48059
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Missouri
Vanda Investigational Site Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Nebraska
Vanda Investigational Site Recruiting
Omaha, Nebraska, United States, 68144
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Nevada
Vanda Investigational Site Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, New Jersey
Vanda Investigational Site Recruiting
Berlin, New Jersey, United States, 08009
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Hoboken, New Jersey, United States, 07030
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
Vanda Investigational Site Recruiting
Verona, New Jersey, United States, 07044
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, New York
Vanda Investigational Site Recruiting
New York, New York, United States, 10022
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
New York, New York, United States, 10075
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, North Carolina
Vanda Investigational Site Recruiting
Charlotte, North Carolina, United States, 28277
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Ohio
Vanda Investigational Site Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Oklahoma
Vanda Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Rhode Island
Vanda Investigational Site Recruiting
Johnston, Rhode Island, United States, 02919
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, South Carolina
Vanda Investigational Site Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
United States, Texas
Vanda Investigational Site Recruiting
Dallas, Texas, United States, 75230
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Houston, Texas, United States, 77065
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
Vanda Investigational Site Recruiting
Mesquite, Texas, United States, 75149
Contact: Vanda Pharmaceuticals         
Contact    202-734-3400      
United States, Utah
Vanda Investigational Site Recruiting
West Jordan, Utah, United States, 84088
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Virginia
Vanda Investigational Site Recruiting
Newport News, Virginia, United States, 23606
Contact: Vanda Pharmaceuticals    202-734-3400      
Vanda Investigational Site Recruiting
Norfolk, Virginia, United States, 23507
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Washington
Vanda Investigational Site Recruiting
Spokane, Washington, United States, 99202
Contact: Vanda Pharmaceuticals    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals
Additional Information:
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04140695    
Other Study ID Numbers: VP-VLY-686-3102
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanda Pharmaceuticals:
Chronic Pruritus
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases