An Open-label Parallel Group Pilot Study to Demonstrate the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa

IRB-300012699

This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.

2025-01-01

2025-09-30

2025-12-31

Not yet recruiting

Early phase I

12

Inclusion Criteria: * Male or Female at least 18 years of age, and provide informed consent prior to study procedures. * Have moderate to severe HS for at least 6 months 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. Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-03-22