A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.

Detailed Description
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A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis. Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups. Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total). All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.

Official Title
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A Double-Blind, Randomised, Placebo Controlled Study of the Efficacy and Safety and Pharmacokinetics of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis

Conditions
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Pruritus, Atopic Dermatitis

Intervention / Treatment
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* Drug: Orvepitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition Subjects must have chronic (> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines Subjects must have atopic dermatitis with a severity > 3 on the IGA and EASI ≥12 at Screening visit/Visit 1 Key Exclusion Criteria: Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2 Inability to comply with the use of prohibited and allowed medications as described in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orvepitant 10mg<br>Orvepitant 10mg tablet, once daily for 12 weeks | Drug: Orvepitant<br>* Tablet, once daily, oral<br>|
| Active Comparator: Orvepitant 20mg<br>Orvepitant 20mg tablet, once daily for 12 weeks | Drug: Orvepitant<br>* Tablet, once daily, oral<br>|
| Active Comparator: Orvepitant 30mg<br>Orvepitant 30mg tablet, once daily for 12 weeks | Drug: Orvepitant<br>* Tablet, once daily, oral<br>|
| Placebo Comparator: Placebo<br>Placebo tablet, once daily for 12 weeks | Drug: Placebo<br>* Tablet, once daily, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Itch Intensity - Numeric Rating Scale | Change from baseline in the mean worst NRS pruritus intensity scores recorded by the subject during the last 3 days of available values in the period prior to the week 12 visit | Week 12 |