Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03568331
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : April 28, 2020
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 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 : June 30, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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

Placebo Comparator: Placebo Drug: Placebo
Oral Capsule

Primary Outcome Measures :
  1. Reduction of worst itch in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Numerical Rating Scale (NRS)

Secondary Outcome Measures :
  1. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by SCORing Atopic Dermatitis (SCORAD) index

  2. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Eczema Area and Severity Index (EASI)

  3. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Investigator Global Assessment for Atopic Dermatitis (IGA-AD)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03568331

Show Show 63 study locations
Sponsors and Collaborators
Vanda Pharmaceuticals
Additional Information:
Layout table for additonal information
Responsible Party: Vanda Pharmaceuticals Identifier: NCT03568331    
Other Study ID Numbers: VP-VLY-686-3101
EPIONE ( Other Identifier: Vanda Pharmaceuticals, Inc. )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases