Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. (HiGUS)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Biological: Guselkumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04061395

CNTO1959HDS2002

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• moderate to severe HS
• treatment history of at least one systemic anti-inflammatory / immunosuppressive agent;
• HS diagnosis of at least 1 year;
• minimum of two anatomical locations with HS lesions
• minimum of 4 active abscesses and/or inflammatory nodules (AN).

Key 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Guselkumab

Experimental group

Description:

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

Treatment:

Biological: Guselkumab