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Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. (HiGUS)

Primary Purpose

Hidradenitis Suppurativa

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Guselkumab
Sponsored by
Barbara Horváth, Principal Investigator
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • moderate to severe HS
  • treatment history of at least one systemic anti-inflammatory / immunosuppressive agent;
  • HS diagnosis of at least 1 year;
  • minimum of two anatomical locations with HS lesions
  • minimum of 4 active abscesses and/or inflammatory nodules (AN).

Key Exclusion Criteria:

  • contra-indication for guselkumab;
  • previous use of guselkumab;
  • use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
  • presence of other uncontrolled major disease;
  • pregnant or lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Guselkumab

    Arm Description

    Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.

    Outcomes

    Primary Outcome Measures

    Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
    Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.

    Secondary Outcome Measures

    Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
    All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.
    Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
    The IHS4 score will be calculated by multiplying the number of nodules by 1, the number of abscesses by 2 and the number of draining fistulas by 4 and adding up these three outcomes into a total score.
    Patient reported outcomes - Patient Global Assessment
    Patient will be asked to assess his or her skin disease activity with in 5 categories.
    Patient reported outcomes - Itch Numeric Rating Scale
    Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).
    Patient reported outcomes - Pain Numeric Rating Scale
    Patient will be asked to score his or her pain on numeric rating scale from 0 (no pain) to 10 (worst possible pain).
    Patient reported outcomes - Patient treatment satisfaction score
    Patient will be asked to score his or her satisfaction about the treatment at baseline and at week 16 on a numeric rating scale from 0 (completely unsatisfied) to 10 (completely satisfied).
    Patient reported outcomes - Dermatology Life Quality Index
    A survey containing 10 questions regarding multiple aspects of the quality of life. Each question has 4 answer possibilities: 'not at all', 'a little', 'a lot' and 'very much'. These answers correspond with 0,1,2 or 3 points respectively. The total score can range from 0 to 30 points.

    Full Information

    First Posted
    August 9, 2019
    Last Updated
    August 19, 2019
    Sponsor
    Barbara Horváth, Principal Investigator
    Collaborators
    Janssen-Cilag Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04061395
    Brief Title
    Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
    Acronym
    HiGUS
    Official Title
    Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Barbara Horváth, Principal Investigator
    Collaborators
    Janssen-Cilag Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin. The total duration of the treatment period per subject is 16 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Guselkumab
    Arm Type
    Experimental
    Arm Description
    Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.
    Intervention Type
    Biological
    Intervention Name(s)
    Guselkumab
    Other Intervention Name(s)
    Tremfya
    Intervention Description
    See study arm description.
    Primary Outcome Measure Information:
    Title
    Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
    Description
    Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.
    Time Frame
    Week 0 and 16
    Secondary Outcome Measure Information:
    Title
    Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
    Description
    All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.
    Time Frame
    Week 0, 4, 12, 16.
    Title
    Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
    Description
    The IHS4 score will be calculated by multiplying the number of nodules by 1, the number of abscesses by 2 and the number of draining fistulas by 4 and adding up these three outcomes into a total score.
    Time Frame
    Week 0, 4, 12, 16.
    Title
    Patient reported outcomes - Patient Global Assessment
    Description
    Patient will be asked to assess his or her skin disease activity with in 5 categories.
    Time Frame
    Every four weeks
    Title
    Patient reported outcomes - Itch Numeric Rating Scale
    Description
    Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).
    Time Frame
    Week 0, 4, 8, 12 and 16
    Title
    Patient reported outcomes - Pain Numeric Rating Scale
    Description
    Patient will be asked to score his or her pain on numeric rating scale from 0 (no pain) to 10 (worst possible pain).
    Time Frame
    Week 0, 4, 8, 12 and 16
    Title
    Patient reported outcomes - Patient treatment satisfaction score
    Description
    Patient will be asked to score his or her satisfaction about the treatment at baseline and at week 16 on a numeric rating scale from 0 (completely unsatisfied) to 10 (completely satisfied).
    Time Frame
    Week 0 and 16
    Title
    Patient reported outcomes - Dermatology Life Quality Index
    Description
    A survey containing 10 questions regarding multiple aspects of the quality of life. Each question has 4 answer possibilities: 'not at all', 'a little', 'a lot' and 'very much'. These answers correspond with 0,1,2 or 3 points respectively. The total score can range from 0 to 30 points.
    Time Frame
    Week 0, 4, 8, 12 and 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: moderate to severe HS treatment history of at least one systemic anti-inflammatory / immunosuppressive agent; HS diagnosis of at least 1 year; minimum of two anatomical locations with HS lesions minimum of 4 active abscesses and/or inflammatory nodules (AN). Key Exclusion Criteria: contra-indication for guselkumab; previous use of guselkumab; use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization; presence of other uncontrolled major disease; pregnant or lactating women

    12. IPD Sharing Statement

    Learn more about this trial

    Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

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