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Trial record 1 of 1 for:    VP-VLY-686-3101
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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.
 
ClinicalTrials.gov Identifier: NCT03568331
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : April 28, 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)
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

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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): NCT03568331


Locations
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Sponsors and Collaborators
Vanda Pharmaceuticals
Additional Information:
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov 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

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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