Phase 2
N=6
Anakinra as a Treatment for Hydradenitis Suppurativa
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT01516749 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in Modified Sartorius Score — -34.8 units on a scale — p=0.024
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- anakinra (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Sartorius Score |
-34.8 | 0.024 sig |
| SECONDARY Change in Quality of Life Assessments |
-45.8; -35.6 | 0.006 sig |
| SECONDARY Change in Dermatology Quality of Life Index (DLQI) |
-8.4 | — |
| SECONDARY Change in C-reactive Protein |
-16.7 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity
Exclusion Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT01516749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.