Anakinra as a Treatment for Hydradenitis Suppurativa
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | October 2012 |
| End Date: | October 2014 |
| Contact: | Kieron S Leslie, M.D. |
| Email: | lesliek@derm.ucsf.edu |
| Phone: | 4152068660 |
An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa
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.
Inclusion Criteria:
1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with
moderate or severe disease activity
Exclusion Criteria:
1. 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)
2. history of immunocompromise including HIV infection
3. positive Hep B surface antigen -
We found this trial at
1
site
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
Click here to add this to my saved trials
