Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. (HiGUS)
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|ClinicalTrials.gov Identifier: NCT04061395|
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Biological: Guselkumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.
See study arm description.
Other Name: Tremfya
- Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab. [ Time Frame: 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.
- Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 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.
- Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4). [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
- Patient reported outcomes - Pain Numeric Rating Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.