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

NCT03464526 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ORV-ADP-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pruritus; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Orvepitant 10mg

ACTIVE COMPARATOR

Orvepitant 10mg tablet, once daily for 12 weeks

Drug: Orvepitant

Orvepitant 20mg

ACTIVE COMPARATOR

Orvepitant 20mg tablet, once daily for 12 weeks

Drug: Orvepitant

Orvepitant 30mg

ACTIVE COMPARATOR

Orvepitant 30mg tablet, once daily for 12 weeks

Drug: Orvepitant

Placebo

PLACEBO COMPARATOR

Placebo tablet, once daily for 12 weeks

Drug: Placebo

Interventions

Orvepitant DRUG

Tablet, once daily, oral

Orvepitant 10mg; Orvepitant 20mg; Orvepitant 30mg

Placebo DRUG

Tablet, once daily, oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nerre Therapeutics Ltd.: lead

MeSH Terms

Conditions

Pruritus; Dermatitis, Atopic

Interventions

orvepitant

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: May 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share