This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.
Male or Female at least 18 years of age, and provide informed consent prior to study procedures.
Have moderate to severe HS classified as Hurley stage II or III for at least 6 months refractory to conventional therapies with a total AN count of greater than or equal to 5 prior to enrollment/randomization
Failed at least 1 course of oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS).
Women of Childbearing potential must have a urine pregnancy test at screening, wk 0 and prior to administration of the study medication
Any other active skin disease that in the opinion of the investigator would interfere with the assessment of HS
Have greater than 20 draining fistulas at screening or Day 1 prior to enrollment/randomization
Receipt of non-biologic treatments for HS within 4 weeks prior to baseline other than antibiotics or hormonal therapy
Receipt of biologic agents within 3 months prior to baseline
Single group
Siplizumab
Drug40 mg doses
Change in inflammatory lesion counts
Inflammatory lesions are defined as inflammatory nodules or abscesses. These will be counted at screening, baseline, weeks 1-4, then at week 6 and 8. We will then asses the average change in inflammatory lesion count per subjects at weeks 4, 8 and 12.
Change in Hidradenitis Suppurativa Clinical Response (HiSCR)
The HiSCR assessment is utilized to show clinical improvement. It is a set of 3 criteria where relative to baseline, each has to be met in order to consider a person's Hidradenitis Suppurativa to be improving. This criteria are as follows: 1. \>50% reduction in the total number of inflammatory nodules and abscesses 2. No increase in abscess count 3. No increase in draining fistula count
Change in Hurley Stage
The Hurley Staging system characterizes the extent of disease in patients with HS. The stages are as follows with 1 having the least involvement and 3 having the most involvement. Stage I: Single of multiple abscess formation without sinus tracts and cicatrization Stage II: Recurrent single or multiple abscesses, widely separated, with limited sinus tracts and cicatrization Stage III: Diffuse or near-diffuse involvement of multiple interconnected tracts and abscesses across an entire area
Change in Dermatology Life Quality Index (DLQI) scores
The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each item has a choice of 4 responses ('not at all', 'a little', 'a lot', and 'very much'. The corresponding scores are '0', '1', '2', or '3'. The total score is the sum of the score of each question. The higher the total score the more a patient's life is affected by their skin condition.
Improvement in Visual Analogue Scale (VAS) pain scores
A 10-point visual analog pain scale will be used with 0 equaling 'no pain' and 10 equaling 'the worst possible pain'.
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University of Alabama at Birmingham
Lead sponsor
ITB-Med LLC
Collaborator
