Guselkumab for the treatment of hidradenitis suppurativa

Phase 1

• Conditions: Hidradenitis suppurativa; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-002978-52-NL
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified