Anakinra as a Treatment for Hydradenitis Suppurativa

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: anakinra


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anakinra<br>All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. | Drug: anakinra<br>* Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.<br>* Other names: Kineret[TM];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 8 weeks | 
| 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 | Baseline, 8 weeks | 
| Change in C-reactive Protein | Change assessed from baseline to end of treatment phase. | Baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hidradenitis suppurativa, anakinra