NCT06326476 Evaluate the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.
| NCT ID | NCT06326476 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Hidradenitis Suppurativa |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-05-09 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-05-09 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.
Eligibility Criteria
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 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
Contact & Investigator
Sarah McClees, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06326476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06326476 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06326476 currently recruiting?
Yes, NCT06326476 is actively recruiting participants. Contact the research team at smcclees@uabmc.edu for enrollment information.
Where is the NCT06326476 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06326476 clinical trial?
NCT06326476 is sponsored by University of Alabama at Birmingham. The principal investigator is Sarah McClees, MD at University of Alabama at Birmingham. The trial plans to enroll 12 participants.