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

Vanda Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Tradipitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04140695

EPIONE2 (Other Identifier)

VP-VLY-686-3102

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

Tradipitant

Experimental group

Description:

Oral Capsule

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Description:

Oral Capsule

Treatment:

Drug: Placebo