Status:
COMPLETED
Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04061395
Start Date
October 1 2019
End Date
April 1 2022
Last Update
April 5 2024
Active Locations (2)
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1
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, Netherlands
2
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ