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

NCT ID: NCT03464526

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2019-10-31

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 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.

Conditions

Pruritus; Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Orvepitant 10mg

Orvepitant 10mg tablet, once daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Orvepitant

Intervention Type: DRUG

Tablet, once daily, oral

Orvepitant 20mg

Orvepitant 20mg tablet, once daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Orvepitant

Intervention Type: DRUG

Tablet, once daily, oral

Orvepitant 30mg

Orvepitant 30mg tablet, once daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Orvepitant

Intervention Type: DRUG

Tablet, once daily, oral

Placebo

Placebo tablet, once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet, once daily, oral

Interventions

Orvepitant

Tablet, once daily, oral

Intervention Type: DRUG

Placebo

Tablet, once daily, oral

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nerre Therapeutics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ORV-ADP-01

Identifier Type: -

Identifier Source: org_study_id