Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Tradipitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02651714

VP-VLY-686-2102

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 treatment-resistant pruritus diagnosed with atopic dermatitis.

Enrollment: 168 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups, including a placebo group

Tradipitant

Experimental group

Description:

Oral

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo