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

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nerre Therapeutics Ltd.

Criteria

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.