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

Atopic Dermatitis Clinical Trial

— SOOTHE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03464526
• Other study ID #: ORV-ADP-01
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2018
• Est. completion date: October 2019

Study information

• Verified date: May 2018
• Source: Nerre Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Drug:
• Orvepitant
Tablet, once daily, oral
• Placebo
Tablet, once daily, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nerre Therapeutics Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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