An Open-label Parallel Group Pilot Study to Demonstrate the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa
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
• Women of childbearing potential must be willing to continue a highly effective method of birth control throughout the study (oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant).
• Negative screening for tuberculosis (TB) (Quantiferon Gold, T-spot) within 3 months prior to screening
• If a positive history of latent tuberculosis:
‣ Currently receiving treatment for latent TB per standard of care
⁃ Have documentation of having completed treatment within 5 years prior to baseline
• Agree not to have a live vaccination during the study.