ectopic acne Hidradenitis suppurativa
Conditions
Interventions
Twenty patients with moderate to severe hidradenitis suppurativa will be
treated with guselkumab 200 mg at week 0, 4, 8 and 12. The total duration of
the treatment period per subject is 16 weeks.
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (* 18 years of age) male or female patients with moderate to severe HS (i.e. a PGA of 3 or more) with a treatment history of at least one systemic anti-in*ammatory / immunosuppressive agent; HS diagnosis of at least 1 year; minimum of two anatomical locations with HS lesions and a minimum of 4 active abscesses and/or inflammatory nodules (AN).
Exclusion criteria
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 |
|---|---|
| A. Expression levels of inflammatory cytokine protein and mRNA in HS lesional skin, compared to perilesional skin and unaffected skin. B. Alterations in serum protein profile (using SOMAscan, Luminex or Olink) | — |
Secondary
| Measure | Time frame |
|---|---|
| C. Clinical efficacy: * Reduction in total AN count * Hidradenitis Suppurativa Clinical Response (HiSCR) * International Hidradenitis Suppurativa Severity Score System (IHS4) * Photographic evaluation D. Patient reported outcomes measures: * Patient global assessment, * Pain Numeric Rating Scale (pain NRS) to assess pain * Itch Numeric Rating Scale (itch NRS) to assess itch * Dermatology Life Quality Index (DLQI) * Hidradenitis Suppurativa Quality of Life (HS-QoL) E. Safety and tolerability: * Vital signs, adverse events, safety laboratories | — |
Countries
Netherlands
Outcome results
None listed