This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.
Subjects will be assigned to receive seven subcutaneous doses of siplizumab over an 8 week period. The study will include up to 3 investigational treatment cohorts, 10 mg, 20 mg and a 40 mg cohort. Each cohort will contain from 3-6 subjects. The cohort will be administered either 10 mg, 20mg, or 40mg siplizumab SC weekly from baseline (week 0) to week 4 and a dose at weeks 6 and 8. Assessments will be performed weekly from baseline (week 0) through week 6 and biweekly through week 12 (weeks 8, 10 \& 12) by an investigator. Weeks 5 and 10 will be telephone visits and will not include physician HS assessments. All other visits will be conducted in person. During all visits, subjects will also be asked to complete a quality of life questionnaire (DLQI) and Visual Analog Scale (VAS) for pain assessment. A total enrollment of 12 subjects is anticipated in this pilot study; however, up to 18 patients may be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
40 mg doses
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGChange 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.
Time frame: 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
Time frame: Weeks 4,8, and 12.
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
Time frame: Weeks 4,8, and 12
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.
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Time frame: Weeks 4, 8, and 12
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'.
Time frame: Weeks 4, 8, and 12
Change in Lesion Counts
All lesions will be counted and examined at each visit to see if there has been a change in the number of lesions from the previous study visit.
Time frame: Weeks 4, 8, and 12