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
University of Alabama at Birmingham
Lead sponsor
ITB-Med LLC
Collaborator