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

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: NCT04140695
Recruitment Status : Completed
First Posted : October 28, 2019
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 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
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tradipitant
Oral Capsule
 Drug: Tradipitant
BID
Placebo Comparator: Placebo
Oral Capsule
 Drug: Placebo
BID


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Vanda Pharmaceuticals
More Information
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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 4, 2022
Last Verified: April 2022

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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