Strategic decision

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.

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.

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.