Clinical trial

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Name

VP-VLY-686-2102

Description

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

Trial arms

Trial start

2016-01-19

Estimated PCD

2017-08-04

Trial end

2017-08-04

Status

Completed

Phase

Early phase I

Treatment

Tradipitant

Arms:

Tradipitant

Placebo

Arms:

Placebo

Size

168

Primary endpoint

Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score

56 days

Eligibility criteria

Inclusion Criteria: * Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive) * Diagnosed with atopic dermatitis * Suffering from chronic pruritus with pruritus being actively present Exclusion Criteria: * Chronic pruritus due to condition other than atopic dermatitis (AD) * Participation in a previous tradipitant (LY686017 or VLY-686) trial * Anyone affiliated with the site or sponsor and/or anyone who may consent under duress * Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 168, 'type': 'ACTUAL'}}

Updated at

2024-06-13

1 organization

1 product

1 drug

1 indication

Organization

Vanda Pharmaceuticals

Product

Tradipitant

Indication

Atopic Dermatitis

Drug

Varlilumab