Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

Study Overview
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Brief Summary
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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.

Official Title
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Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Biological: Guselkumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guselkumab<br>Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks. | Biological: Guselkumab<br>* See study arm description.<br>* Other names: Tremfya;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 0, 4, 12, 16. | 
| 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. | Week 0, 4, 12, 16. | 
| Patient reported outcomes - Patient Global Assessment | Patient will be asked to assess his or her skin disease activity with in 5 categories. | Every four weeks | 
| 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). | Week 0, 4, 8, 12 and 16 | 
| 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). | Week 0, 4, 8, 12 and 16 | 
| 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). | Week 0 and 16 | 
| 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. | Week 0, 4, 8, 12 and 16 |