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

May 9, 2018 updated by: Nerre Therapeutics Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Orvepitant 10mg
Orvepitant 10mg tablet, once daily for 12 weeks
Drug: Orvepitant
Tablet, once daily, oral
Active Comparator: Orvepitant 20mg
Orvepitant 20mg tablet, once daily for 12 weeks
Drug: Orvepitant
Tablet, once daily, oral
Active Comparator: Orvepitant 30mg
Orvepitant 30mg tablet, once daily for 12 weeks
Drug: Orvepitant
Tablet, once daily, oral
Placebo Comparator: Placebo
Placebo tablet, once daily for 12 weeks
Drug: Placebo
Tablet, once daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Itch Intensity - Numeric Rating Scale
Time Frame: Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nerre Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORV-ADP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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