Siplizumab for Hidradenitis Suppurativa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a new treatment, siplizumab, for individuals with Hidradenitis Suppurativa (HS), a skin condition that causes painful lumps under the skin. Participants will receive varying doses of siplizumab to assess its impact on their symptoms. The trial suits those who have experienced moderate to severe HS for at least six months, have not improved with standard treatments, and have tried oral antibiotics without success. As an Early Phase 1 trial, this research aims to understand how siplizumab works in people, offering participants the opportunity to be among the first to receive this innovative treatment.
Do I need to stop my current medications to join the trial?
The trial requires that you stop certain medications before joining. You must not have taken non-biologic treatments for HS, biologic agents, or any investigational products within a specified time before the trial. However, if you are on a steady dose of doxycycline or tetracycline antibiotics, you can continue them during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is exploring siplizumab as a potential treatment for hidradenitis suppurativa, a skin condition that causes inflammation. Siplizumab remains in the early testing stages, requiring more information about its safety for humans.
This trial is in its first phase, providing limited safety information. The phase aims to determine the treatment's safety for people. Researchers have yet to establish how well people can tolerate siplizumab or what side effects might occur.
If siplizumab has been used in other studies or for other conditions, it might offer some insights into its safety. However, the primary goal is to ensure its safety for people with hidradenitis suppurativa. Participants in the trial will contribute to gathering this crucial information.12345Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?
Unlike the standard treatments for Hidradenitis Suppurativa, which often include antibiotics, steroids, or biologics like adalimumab, siplizumab offers a novel approach by targeting a different pathway. Siplizumab is a monoclonal antibody that focuses on modulating the immune response, potentially reducing inflammation more effectively. Researchers are excited because this could mean a more targeted treatment with fewer side effects, offering new hope for patients who have not responded well to existing therapies. Additionally, the subcutaneous delivery of siplizumab might provide a more convenient and less invasive option compared to intravenous infusions, which are common with some current treatments.
What evidence suggests that siplizumab might be an effective treatment for Hidradenitis Suppurativa?
Research has shown that siplizumab might help treat hidradenitis suppurativa. In one study, participants who responded early to siplizumab experienced significant skin improvements over two years. Another study found that over 60% of patients had a noticeable reduction in symptoms by week 12. This trial will test different dosages of siplizumab, with participants receiving a 10 mg, 20 mg, or 40 mg subcutaneous dose. Siplizumab targets specific immune cells that cause inflammation, aiming to reduce the painful lumps and bumps associated with the condition.13467
Who Is on the Research Team?
Tiffany Mayo, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for individuals with moderate to severe Hidradenitis Suppurativa (HS) who have tried at least one oral antibiotic treatment without success or cannot take them. They must not have active tuberculosis but should be on treatment if they have latent TB. Women capable of having children need a negative pregnancy test and must use effective birth control during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous doses of siplizumab over an 8-week period, with weekly doses from baseline to week 4 and additional doses at weeks 6 and 8
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of HiSCR, DLQI, lesion counts, and VAS pain scores
What Are the Treatments Tested in This Trial?
Interventions
- Siplizumab
Trial Overview
The trial is testing Siplizumab, administered subcutaneously, to see how safe and effective it is in treating HS. It's an open-label study where everyone knows what treatment they're getting, with increasing doses over time to find the right balance between safety and effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
ITB-Med LLC
Industry Sponsor
Citations
Study Details | NCT06326476 | An Open-label, Time- ...
An Open-label, Time-lagged, Dose-escalation Study to Evalaute the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.
Siplizumab – Application in Therapy and Current Clinical ...
This article explores the ongoing research into siplizumab's potential as a treatment for diseases like type 1 diabetes, hidradenitis suppurativa, autoimmune ...
Real‐World Clinical Outcomes and Lipid Profile Evaluation
Early Responders demonstrated substantial and sustained improvements in IHS4, A/N count, and HS-IGA scores over a 104-week period. These results ...
The Current Clinical Trial Landscape for Hidradenitis ...
One of the secondary outcomes was HiSCR, and 63% of patients in group A and 61% of patients in group B achieved HiSCR at week 12. Possible ...
NK and NKT cells in the pathogenesis of Hidradenitis ...
The data from preceding experiments suggest that distinct NKT and NK cell populations mediate type 1 (inflammatory/cytolytic) and type 2 ( ...
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ctv.veeva.com
ctv.veeva.com/study/a-study-to-demonstrate-the-safety-and-efficacy-of-siplizumab-in-the-treatment-of-hidradenitis-suppurAn Open-label, Time-lagged, Dose-escalation Study to ...
This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.
A Systematic Review and Network Meta-Analysis - PMC
Efficacy and safety of bimekizumab in moderate to severe hidradenitis suppurativa: A phase 2, double-blind, placebo-controlled randomized ...
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