A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Janssen-Cilag B.V.
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• 18 years or older

• Hidradenitis suppurativa Hurley stage II or III

• No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery

• The patient has to be able to complete a dutch questionnaire

• Informed consent must be obtained

Exclusion Criteria:

• Not able to complete a Dutch questionnaire

• Pregnancy or breast feeding

• Active hepatitis B or C infection, HIV or tuberculosis

• Treatment with biologics or other immunosuppressive medicine in the previous 3 months

• Malignancies in the last 10 years with the exception of basal cell carcinoma

• Demyelinating disorders

• Heart failure

• Known allergy to ustekinumab or to its preservatives

• Live vaccins in the next 3 months Sever liver or renal failure