Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Biological: Guselkumab
- Registration Number
- NCT04061395
- Lead Sponsor
- University Medical Center Groningen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Guselkumab Guselkumab Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.
- Primary Outcome Measures
Name Time Method Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab. Week 0 and 16 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
Name Time Method Patient reported outcomes - Pain Numeric Rating Scale Week 0, 4, 8, 12 and 16 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 Week 0 and 16 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 Week 0, 4, 8, 12 and 16 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.
Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4). Week 0, 4, 12, 16. 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.
Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR) Week 0, 4, 12, 16. All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.
Patient reported outcomes - Patient Global Assessment Every four weeks Patient will be asked to assess his or her skin disease activity with in 5 categories.
Patient reported outcomes - Itch Numeric Rating Scale Week 0, 4, 8, 12 and 16 Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).
Trial Locations
- Locations (2)
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Erasmus MC, University Medical Center Rotterdam
🇳🇱Rotterdam, Zuid-Holland, Netherlands