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

NCT06326476 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: IRB-300012699000544067
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory lesion counts

  Inflammatory lesions are defined as inflammatory nodules or abscesses. These will be counted at screening, baseline, weeks 1-4, then at week 6 and 8. We will then asses the average change in inflammatory lesion count per subjects at weeks 4, 8 and 12.

  Weeks 4, 8 and 12

Secondary Outcomes (5)

• Change in Hidradenitis Suppurativa Clinical Response (HiSCR)

  Weeks 4,8, and 12.

• Change in Hurley Stage

  Weeks 4,8, and 12

• Change in Dermatology Life Quality Index (DLQI) scores

  Weeks 4, 8, and 12

• Improvement in Visual Analogue Scale (VAS) pain scores

  Weeks 4, 8, and 12

• Change in Lesion Counts

  Weeks 4, 8, and 12

Study Arms (3)

siplizumab 10mg

EXPERIMENTAL

Up to 6 participants may receive a 10 mg subcutaneous dose of siplizumab from week 0 to week 4 then at weeks 6 and 8.

Drug: Siplizumab

siplizumab 20mg

EXPERIMENTAL

Up to 6 participants may receive a 20 mg subcutaneous dose of siplizumab from week 0 to week 4 then at weeks 6 and 8.

Drug: Siplizumab

siplizumab 40mg

EXPERIMENTAL

Up to 6 participants may receive a 40 mg subcutaneous dose of siplizumab from week 0 to week 4 then at weeks 6 and 8.

Drug: Siplizumab

Interventions

Siplizumab DRUG

40 mg doses

siplizumab 10mg; siplizumab 20mg; siplizumab 40mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• ITB-Med LLC: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

siplizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Tiffany Mayo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralee' Bunt, MSPH

CONTACT

205-502-9960; erikabunt@uabmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: May 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)