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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Ralee' Bunt, MSPH
erikabunt@uabmc.edu
205-502-9960
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 12
Treatments
Experimental: siplizumab 10mg
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.
Experimental: siplizumab 20mg
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.
Experimental: siplizumab 40mg
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.
Related Therapeutic Areas
Sponsors
Collaborators: ITB-Med LLC
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov