Actively Recruiting
An Open-label, Time-lagged, Dose-escalation Study to Evalaute the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.
Led by University of Alabama at Birmingham · Updated on 2025-05-29
12
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
I
ITB-Med LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.
CONDITIONS
Official Title
An Open-label, Time-lagged, Dose-escalation Study to Evalaute the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female at least 18 years old and able to provide informed consent
- Diagnosed with moderate to severe Hidradenitis Suppurativa (Hurley stage II or III) for at least 6 months
- Have at least 5 active lesions prior to enrollment
- Have failed at least one course of oral antibiotics for Hidradenitis Suppurativa or have intolerance/contraindication to such antibiotics
- Women of childbearing potential must have a negative pregnancy test at screening, week 0, and before study medication
- Women of childbearing potential must agree to use effective birth control throughout the study
- Negative tuberculosis screening within 3 months prior to screening
- If history of latent tuberculosis, must be currently treated or have completed treatment within 5 years
- Agree not to receive live vaccinations during the study
You will not qualify if you...
- Presence of other active skin diseases interfering with HS assessment
- More than 20 draining fistulas at screening or prior to enrollment
- Use of non-biologic HS treatments other than antibiotics or hormonal therapy within 4 weeks before baseline
- Use of biologic agents within 3 months before baseline
- Use of other investigational products within 3 months before baseline
- New oral antibiotics or hormonal therapy within 6 weeks before baseline, except steady doxycycline or tetracycline use
- Intralesional kenalog injections within 2 weeks before baseline
- Uncontrolled medical conditions interfering with study assessments
- Current malignancy or history of malignancy within 5 years (except certain skin or cervical cancers)
- Ongoing, chronic, or recurrent infections
- Pregnant, breastfeeding, or planning pregnancy during the study
- Previous hypersensitivity to siplizumab or its components
- Known infection with HIV, hepatitis B or C
- Significant immunocompromising conditions or unacceptable risk for immunomodulatory therapy
- Certain laboratory abnormalities within 30 days before enrollment including low white blood cell count, low platelet count, low hemoglobin, elevated liver enzymes, high serum creatinine, positive SARS-CoV-2 test, or low lymphocyte count
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
R
Ralee' Bunt, MSPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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