Phase 3 N=375 Randomized Quadruple-blind Treatment

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

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT03568331 ↗

Enrolled (actual)

375

Serious AEs

0.8%

Results posted

May 2024

Primary outcome: Primary: Reduction of Worst Itch in Atopic Dermatitis — -3.6; -3.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tradipitant (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanda Pharmaceuticals
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction of Worst Itch in Atopic Dermatitis	-3.6; -3.5	—
SECONDARY Improvement of Disease Severity in Atopic Dermatitis	51; 54	—
SECONDARY Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction	37; 36	—

Summary

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

Eligibility 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 8 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03568331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.