Hidradenitis Suppurativa
Conditions
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.
Interventions
BIOLOGICALGuselkumab
See study arm description.
Sponsors
Janssen-Cilag Ltd.
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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 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. |
| 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). |
Countries
Netherlands
Outcome results
None listed