Guselkumab for hidradenitis suppurativa, a mode of action study.

Phase 2

Completed

Conditions: ectopic acne
Hidradenitis suppurativa
10040785

Registration Number: NL-OMON48592

Lead Sponsor: niversitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A. Expression levels of inflammatory cytokine protein and mRNA in HS lesional<br /><br>skin, compared to perilesional skin and unaffected skin.<br /><br>B. Alterations in serum protein profile (using SOMAscan, Luminex or Olink)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>C. Clinical efficacy:<br /><br>* Reduction in total AN count<br /><br>* Hidradenitis Suppurativa Clinical Response (HiSCR)<br /><br>* International Hidradenitis Suppurativa Severity Score System (IHS4)<br /><br>* Photographic evaluation<br /><br>D. Patient reported outcomes measures:<br /><br>* Patient global assessment,<br /><br>* Pain Numeric Rating Scale (pain NRS) to assess pain<br /><br>* Itch Numeric Rating Scale (itch NRS) to assess itch<br /><br>* Dermatology Life Quality Index (DLQI)<br /><br>* Hidradenitis Suppurativa Quality of Life (HS-QoL)<br /><br>E. Safety and tolerability:<br /><br>* Vital signs, adverse events, safety laboratories </p><br>