Siplizumab for Hidradenitis Suppurativa

Overseen By Ralee' Bunt, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must be taking: Doxycycline, Tetracycline

Must not be taking: Biologics, Investigational products

Disqualifiers: Active skin disease, Malignancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Tiffany Mayo, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

I am currently being treated for latent TB.

I agree to use effective birth control during the study.

I will undergo pregnancy tests before and during the study if I can have children.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

8 weeks

Weekly visits from baseline to week 6, biweekly visits through week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of HiSCR, DLQI, lesion counts, and VAS pain scores

4 weeks

Biweekly visits at weeks 8, 10, and 12

Treatment Details

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.

Participant Groups

Group I: siplizumab 40mg Experimental Treatment 1 Intervention

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.

Group II: siplizumab 20mg Experimental Treatment 1 Intervention

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.

Group III: siplizumab 10mg Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

ITB-Med LLC

Industry Sponsor

Trials

12

Recruited

390+