Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

Sponsor
University Medical Center Groningen
Study ID
NCT04061395
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — BIOLOGICAL
    See study arm description.

Study Details

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.

Key Dates

Start date
Oct 1, 2019
Status verified
Apr 2024
Primary completion
Dec 30, 2021
Completion
Apr 1, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Guselkumab
    Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.

Primary Outcome Measure

Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab. [ Time Frame: Week 0 and 16 ]

Related Studies