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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Tradipitant; Drug: Placebo

• Registration Number: NCT03568331
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-26
• Study Start: 2018-07-09
• Primary Completion: 2019-12-27
• Study Completion: 2019-12-27
• Results First Submitted: 2024-03-19
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Results First Posted: 2024-05-13
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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 8 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tradipitant	Tradipitant	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Reduction of Worst Itch in Atopic Dermatitis	8 weeks	Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours \[0=No Itch, 10=Worst Itch Imaginable\].

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction	8 weeks	As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting.
Improvement of Disease Severity in Atopic Dermatitis	8 weeks	Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Spokane, Washington, United States