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

Primary Purpose

Pruritus, Atopic Dermatitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Orvepitant
Placebo
Sponsored by
Nerre Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Orvepitant 10mg

    Orvepitant 20mg

    Orvepitant 30mg

    Placebo

    Arm Description

    Orvepitant 10mg tablet, once daily for 12 weeks

    Orvepitant 20mg tablet, once daily for 12 weeks

    Orvepitant 30mg tablet, once daily for 12 weeks

    Placebo tablet, once daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2018
    Last Updated
    May 9, 2018
    Sponsor
    Nerre Therapeutics Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03464526
    Brief Title
    A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Strategic decision
    Study Start Date
    May 2018 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nerre Therapeutics Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pruritus, Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Orvepitant 10mg
    Arm Type
    Active Comparator
    Arm Description
    Orvepitant 10mg tablet, once daily for 12 weeks
    Arm Title
    Orvepitant 20mg
    Arm Type
    Active Comparator
    Arm Description
    Orvepitant 20mg tablet, once daily for 12 weeks
    Arm Title
    Orvepitant 30mg
    Arm Type
    Active Comparator
    Arm Description
    Orvepitant 30mg tablet, once daily for 12 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablet, once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Orvepitant
    Intervention Description
    Tablet, once daily, oral
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Tablet, once daily, oral
    Primary Outcome Measure Information:
    Title
    Change in Itch Intensity - Numeric Rating Scale
    Description
    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
    Time Frame
    Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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