Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
HiGUS
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 5, 2024
April 1, 2024
2.2 years
August 9, 2019
April 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 0 and 16
Secondary Outcomes (7)
Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
Week 0, 4, 12, 16.
Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
Week 0, 4, 12, 16.
Patient reported outcomes - Patient Global Assessment
Every four weeks
Patient reported outcomes - Itch Numeric Rating Scale
Week 0, 4, 8, 12 and 16
Patient reported outcomes - Pain Numeric Rating Scale
Week 0, 4, 8, 12 and 16
- +2 more secondary outcomes
Study Arms (1)
Guselkumab
EXPERIMENTALGuselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Janssen-Cilag Ltd.collaborator
Study Sites (2)
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 19, 2019
Study Start
October 1, 2019
Primary Completion
December 30, 2021
Study Completion
April 1, 2022
Last Updated
April 5, 2024
Record last verified: 2024-04