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
About this trial
This is an interventional other trial for Hidradenitis Suppurativa
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
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
NCT ID
NCT04061395
First Posted
August 9, 2019
Last Updated
August 19, 2019
Sponsor
Barbara Horváth, Principal Investigator
Collaborators
Janssen-Cilag Ltd.
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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