Status:
WITHDRAWN
A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
Lead Sponsor:
Nerre Therapeutics Ltd.
Conditions:
Pruritus
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03464526
Start Date
May 1 2018
End Date
October 1 2019
Last Update
May 15 2018
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