Laguna Hills, California 92653

  • Atopic Dermatitis

Purpose:

This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.


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


Study is Available At:


Original ID:

VP-VLY-686-3102


NCT ID:

NCT04140695


Secondary ID:


Study Acronym:

EPIONE2


Brief Title:

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


Official Title:

A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanda Pharmaceuticals


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

87


Enrollment Type:

Actual


Study Dates

Start Date:October 21, 2019
Completion Date:October 14, 2020
Completion Type:Actual
Primary Completion Date:October 14, 2020
Primary Completion Type:Actual
Verification Date:April 2022
Last Changed Date:April 28, 2022
First Received Date:October 24, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reduction of worst itch in atopic dermatitis
Time Frame:8 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Improvement of disease severity in atopic dermatitis
Time Frame:8 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Improvement of disease severity in atopic dermatitis
Time Frame:8 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Improvement of disease severity in atopic dermatitis
Time Frame:8 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:BID
Arm Name:Placebo
Intervention Type:Drug
Name:Tradipitant
Description:BID
Arm Name:Tradipitant

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Oral Capsule
Study Arm Type:Experimental
Arm Name:Tradipitant
Description:Oral Capsule

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Vanda Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 01, 2023

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