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A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

Subjects will be assigned to receive seven subcutaneous doses of siplizumab over an 8 week period. 12 subjects will be given 40 mg weekly from baseline (week 0) to week 4 and a 40 mg dose at weeks 6 and 8. Assessments will be performed weekly from baseline (week 0) through week 6 and biweekly through week 12 (weeks 8, 10 & 12) by an investigator. Weeks 5 and 10 will be telephone visits and will not include physician HS assessments. All other visits will be conducted in person. During all visits, subjects will also be asked to complete a quality of life questionnaire (DLQI) and Visual Analog Scale (VAS) for pain assessment. A total enrollment of 12 subjects is anticipated in this pilot study ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06326476
Study type Interventional
Source University of Alabama at Birmingham
Contact Ralee' Bunt, MSPH
Phone 205-502-9960
Email erikabunt@uabmc.edu
Status Not yet recruiting
Phase Early Phase 1
Start date January 2025
Completion date December 31, 2025
View Details
See also
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