NCT03464526

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nerre Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Orvepitant	Tablet, once daily, oral
DRUG	Placebo	Tablet, once daily, oral

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-06-01
• Completion: 2019-10-01
• First posted: 2018-03-14
• Last updated: 2018-05-15

Regulatory

• FDA-regulated drug study