University of Alabama at Birmingham
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…
Inclusion Criteria: * 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…
40 mg doses
Arctuva estimate
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