Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
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

Tracking Information
First Submitted Date  ICMJE June 13, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date April 28, 2020
Actual Study Start Date  ICMJE June 30, 2018
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
Reduction of worst itch in atopic dermatitis [ Time Frame: 8 weeks ]
As measured by Numerical Rating Scale (NRS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by SCORing Atopic Dermatitis (SCORAD) index
  • Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Eczema Area and Severity Index (EASI)
  • Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Investigator Global Assessment for Atopic Dermatitis (IGA-AD)
  • Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Tradipitant
    Oral Capsule
  • Drug: Placebo
    Oral Capsule
Study Arms  ICMJE
  • Experimental: Tradipitant
    Intervention: Drug: Tradipitant
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2020)
375
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
500
Actual Study Completion Date  ICMJE February 1, 2020
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03568331
Other Study ID Numbers  ICMJE VP-VLY-686-3101
EPIONE ( Other Identifier: Vanda Pharmaceuticals, Inc. )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vanda Pharmaceuticals
Study Sponsor  ICMJE Vanda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP