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NCT04140695 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04140695
Other study ID # VP-VLY-686-3102
Secondary ID EPIONE2
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 21, 2019
Est. completion date October 14, 2020

Study information
Verified date April 2024
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 87
Est. completion date October 14, 2020
Est. primary completion date October 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tradipitant
BID
• Placebo
BID

Locations
Country Name City State
United States Vanda Investigational Site Alexandria Virginia
United States Vanda Investigational Site Berlin New Jersey
United States Vanda Investigational Site Boise Idaho
United States Vanda Investigational Site Bronx New York
United States Vanda Investigational Site Charlotte North Carolina
United States Vanda Investigational Site Chicago Illinois
United States Vanda Investigational Site Cincinnati Ohio
United States Vanda Investigational Site Clearwater Florida
United States Vanda Investigational Site Crowley Louisiana
United States Vanda Investigational Site Dallas Texas
United States Vanda Investigational Site Denver Colorado
United States Vanda Investigational Site Encino California
United States Vanda Investigational Site Fort Gratiot Michigan
United States Vanda Investigational Site Fountain Valley California
United States Vanda Investigational Site Hoboken New Jersey
United States Vanda Investigational Site Hoover Alabama
United States Vanda Investigational Site Houston Texas
United States Vanda Investigational Site Houston Texas
United States Vanda Investigational Site Johnston Rhode Island
United States Vanda Investigational Site Kew Gardens New York
United States Vanda Investigational Site Laguna Hills California
United States Vanda Investigational Site Las Vegas Nevada
United States Vanda Investigational Site Lomita California
United States Vanda Investigational Site Los Angeles California
United States Vanda Investigational Site Los Angeles California
United States Vanda Investigational Site Los Angeles California
United States Vanda Investigational Site Mesquite Texas
United States Vanda Investigational Site Miami Florida
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site Newport News Virginia
United States Vanda Investigational Site Norfolk Virginia
United States Vanda Investigational Site Normal Illinois
United States Vanda Investigational Site Oklahoma City Oklahoma
United States Vanda Investigational Site Omaha Nebraska
United States Vanda Investigational Site Philadelphia Pennsylvania
United States Vanda Investigational Site Plainfield Indiana
United States Vanda Investigational Site Saint Joseph Missouri
United States Vanda Investigational Site Saint Louis Missouri
United States Vanda Investigational Site Savannah Georgia
United States Vanda Investigational Site Skokie Illinois
United States Vanda Investigational Site South Burlington Vermont
United States Vanda Investigational Site South Jordan Utah
United States Vanda Investigational Site Spartanburg South Carolina
United States Vanda Investigational Site Spartanburg South Carolina
United States Vanda Investigational Site Spokane Washington
United States Vanda Investigational Site Tampa Florida
United States Vanda Investigational Site Tempe Arizona
United States Vanda Investigational Site Timonium Maryland
United States Vanda Investigational Site Tulsa Oklahoma
United States Vanda Investigational Site Verona New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable". 2 weeks
See also
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Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
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Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

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