Anakinra as a Treatment for Hydradenitis Suppurativa

Completed · Phase 2

Conditions studied: Hidradenitis Suppurativa

In brief

This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.

Key facts

Study ID

NCT01516749

Run by

University of California, San Francisco

People needed

6

Starts

2012-10-01

Expected to finish

2013-07-01

Last updated by the study team

2014-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity

You may not qualify if…

• Use of the following therapies:
• Etanercept in the 4 weeks prior to the baseline visit (Day 1)
• Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
• Infliximab in the 12 weeks prior to the baseline visit (Day 1)
• Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
• Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
• Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
• I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
• 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
• Colchicine, dapsone, mycophenolate mofetil \& systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
• Corticosteroids "20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
• history of immunocompromise including HIV infection
• positive Hep B surface antigen -

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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