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

NeRRe Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Atopic Dermatitis; Pruritus

Treatments: Drug: Placebo; Drug: Orvepitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03464526

ORV-ADP-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Orvepitant 10mg

Active Comparator group

Description:

Orvepitant 10mg tablet, once daily for 12 weeks

Treatment:

Drug: Orvepitant

Orvepitant 20mg

Active Comparator group

Description:

Orvepitant 20mg tablet, once daily for 12 weeks

Treatment:

Drug: Orvepitant

Orvepitant 30mg

Active Comparator group

Description:

Orvepitant 30mg tablet, once daily for 12 weeks

Treatment:

Drug: Orvepitant

Placebo

Placebo Comparator group

Description:

Placebo tablet, once daily for 12 weeks

Treatment:

Drug: Placebo