RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05-09

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06326476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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. * 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

Inclusion Criteria

Exclusion 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.

* 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.
* 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

Contacts and Locations

Study Contact

Ralee' Bunt, MSPH

CONTACT

205-502-9960

erikabunt@uabmc.edu

Principal Investigator

Tiffany Mayo, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Tiffany Mayo, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-09

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-05-09

Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

Hidradenitis Suppurativa