An Open-label, Time-lagged, Dose-escalation Study to Evalaute the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.

Exclusion Criteria26

• 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
• Receipt of any other investigational product within 3 months prior to baseline
• Receipt of new oral antibiotics or hormonal therapy within 6 weeks prior to baseline.
• Subjects may be included if they are on steady dose of doxycycline or tetracycline antibiotics only for at least 6 weeks prior to baseline visit and may not change or discontinue dose during course of study.
• Receipt of intralesional kenalog injections within 2 weeks prior to baseline
• Any uncontrolled diagnosis or condition that in the opinion of the investigator will interfere with the assessments or the study.
• Currently has a malignancy or a history of a malignancy within 5 years before screen (except successfully treated non-melanoma skin cancer or cervical carcinoma in situ)
• History of an ongoing, chronic or recurrent infectious disease
• Are currently pregnant, breastfeeding, or planning to get pregnant during the study.
• Previous hypersensitivity reaction to siplizumab or to any of the components
• Known infection with HIV, hepatitis B or hepatitis C at screening or randomization.
• Patients who are Hepatitis B Core antibody and/or Hep B Surface Antigen positive will be excluded from this study. Patients who are Hepatitis C ab positive will also be excluded from this study.
• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
• Any of the following laboratory abnormalities within 30 days of enrollment:
• White blood count (WBC) < 3 x 103/μL;,
• CD4+ count below the lower limit of normal,
• Platelet count < 150,000 /μL,
• Hemoglobin < 10 g/dL,
• ALT ≥ 2x upper limit of normal (ULN) or
• AST ≥ 2x ULN
• Serum creatinine >1.5x ULN in adults.
• Positive molecular testing of SARS-CoV-2
• ALC less than 800 lymphocytes/mm3