Back to resultsAnakinra as a Treatment for Hydradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anakinra
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring hidradenitis suppurativa, anakinra
Eligibility Criteria
Inclusion Criteria:
1) 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 -
Sites / Locations
- San Francisco General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anakinra
Arm Description
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Outcomes
Primary Outcome Measures
Change in Modified Sartorius Score
At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.
Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.
Secondary Outcome Measures
Change in Quality of Life Assessments
The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).
The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked "What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?" with a scale of 0=no acitivity to 100=maximal activity.
Change in Dermatology Quality of Life Index (DLQI)
Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life
Change in C-reactive Protein
Change assessed from baseline to end of treatment phase.
Full Information
NCT ID
NCT01516749
First Posted
December 7, 2011
Last Updated
August 15, 2014
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01516749
Brief Title
Anakinra as a Treatment for Hydradenitis Suppurativa
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
hidradenitis suppurativa, anakinra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anakinra
Arm Type
Experimental
Arm Description
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Intervention Type
Drug
Intervention Name(s)
anakinra
Other Intervention Name(s)
Kineret[TM]
Intervention Description
Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Primary Outcome Measure Information:
Title
Change in Modified Sartorius Score
Description
At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.
Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life Assessments
Description
The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).
The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked "What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?" with a scale of 0=no acitivity to 100=maximal activity.
Time Frame
Baseline, 8 weeks
Title
Change in Dermatology Quality of Life Index (DLQI)
Description
Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life
Time Frame
Baseline, 8 weeks
Title
Change in C-reactive Protein
Description
Change assessed from baseline to end of treatment phase.
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kieron S Leslie, M.D.
Organizational Affiliation
University of California, San Francisco - Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18674845
Citation
Revuz JE, Canoui-Poitrine F, Wolkenstein P, Viallette C, Gabison G, Pouget F, Poli F, Faye O, Roujeau JC, Bonnelye G, Grob JJ, Bastuji-Garin S. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol. 2008 Oct;59(4):596-601. doi: 10.1016/j.jaad.2008.06.020.
Results Reference
background
PubMed Identifier
2934550
Citation
Fitzsimmons JS, Guilbert PR. A family study of hidradenitis suppurativa. J Med Genet. 1985 Oct;22(5):367-73. doi: 10.1136/jmg.22.5.367.
Results Reference
background
PubMed Identifier
16093838
Citation
Stojanov S, Kastner DL. Familial autoinflammatory diseases: genetics, pathogenesis and treatment. Curr Opin Rheumatol. 2005 Sep;17(5):586-99. doi: 10.1097/bor.0000174210.78449.6b.
Results Reference
background
PubMed Identifier
17039195
Citation
Steinhoff JP, Cilursu A, Falasca GF, Guzman L, Reginato AJ. A study of musculoskeletal manifestations in 12 patients with SAPHO syndrome. J Clin Rheumatol. 2002 Feb;8(1):13-22. doi: 10.1097/00124743-200202000-00005.
Results Reference
background
PubMed Identifier
15897171
Citation
Rosi YL, Lowe L, Kang S. Treatment of hidradenitis suppurativa with infliximab in a patient with Crohn's disease. J Dermatolog Treat. 2005 Feb;16(1):58-61. doi: 10.1080/09546630410024547.
Results Reference
background
PubMed Identifier
18241264
Citation
Hunger RE, Surovy AM, Hassan AS, Braathen LR, Yawalkar N. Toll-like receptor 2 is highly expressed in lesions of acne inversa and colocalizes with C-type lectin receptor. Br J Dermatol. 2008 Apr;158(4):691-7. doi: 10.1111/j.1365-2133.2007.08425.x. Epub 2008 Jan 30.
Results Reference
background
PubMed Identifier
15125785
Citation
Sakai A, Han J, Cato AC, Akira S, Li JD. Glucocorticoids synergize with IL-1beta to induce TLR2 expression via MAP Kinase Phosphatase-1-dependent dual Inhibition of MAPK JNK and p38 in epithelial cells. BMC Mol Biol. 2004 May 4;5:2. doi: 10.1186/1471-2199-5-2.
Results Reference
background
PubMed Identifier
17178985
Citation
Leslie KS, Lachmann HJ, Bruning E, McGrath JA, Bybee A, Gallimore JR, Roberts PF, Woo P, Grattan CE, Hawkins PN. Phenotype, genotype, and sustained response to anakinra in 22 patients with autoinflammatory disease associated with CIAS-1/NALP3 mutations. Arch Dermatol. 2006 Dec;142(12):1591-7. doi: 10.1001/archderm.142.12.1591.
Results Reference
background
PubMed Identifier
19438453
Citation
Sartorius K, Emtestam L, Jemec GB, Lapins J. Objective scoring of hidradenitis suppurativa reflecting the role of tobacco smoking and obesity. Br J Dermatol. 2009 Oct;161(4):831-9. doi: 10.1111/j.1365-2133.2009.09198.x. Epub 2009 Apr 29.
Results Reference
background
Learn more about this trial
Anakinra as a Treatment for Hydradenitis Suppurativa
We'll reach out to this number within 24 hrs