Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

• Sponsor: Vanda Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02651714
• Collaborator: (none)
• Enrollment: 168
• Locations: 5
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 33.6
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis; Eczema; Chronic Pruritus	Drug: Tradipitant; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Oral	Drug: Placebo
Experimental: Tradipitant Oral	Drug: Tradipitant

Outcome Measures

Primary Outcome Measures

1. Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS). [Starting at week 2.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States
2		New York	New York	United States
3		High Point	North Carolina	United States
4		Wilmington	North Carolina	United States
5		Pflugerville	Texas	United States

Sponsors and Collaborators

• Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02651714
• Other Study ID Numbers: VP-VLY-686-2102; NCT02672410
• First Posted: Jan 11, 2016
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus

Study Results

No Results Posted as of Nov 6, 2017