Status:
COMPLETED
Anakinra as a Treatment for Hydradenitis Suppurativa
Lead Sponsor:
University of California, San Francisco
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 1\) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity
Exclusion
- 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 -
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01516749
Start Date
October 1 2012
End Date
July 1 2013
Last Update
August 20 2014
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110