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Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Hidradenitis Suppurativa Clinical Trial

Official title:
A Pilot Study Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo in the Treatment of Moderate-to-severe Hidradenitis Suppurativa (HS).

Clinical Trial Summary

The study is a randomized, proof of concept study. 30 patients aged 18 and over with HS will be included in this single center, randomized, double-blind, parallel-group study. Dosage of deucravacitinib will be given according to the investigational regimen as follows: 6 mg po bid for 16 weeks. The study compromises a 4-week screening period, a 16-week study period, and a 4-week follow-up period. The follow-up period consists of a follow-up phone call 4 weeks after the last study drug dose.

Clinical Trial Description

The objective of this study is to investigate the efficacy of Deucravacitinib (BMS- 986165) in the treatment of Hidradenitis Suppurativa. Subjects will be randomly assigned to receive either Deucravacitinib (6 mg twice daily) or placebo for 16 weeks. Assessments will be performed at Baseline and weeks 4, 8, 12, and 16 by a blinded investigator. During this visits, subjects will also be asked to complete a quality of life questionnaire (DLQI) and Visual Analog Scale (VAS) for pain. A total enrollment of 30 subjects (20 study drug, 10 placebo) is anticipated in this single- center, randomized, double-blind, parallel-group study. This study powered to show a significant difference in efficacy of treatment using the following assumptions based on other clinical trials: baseline average inflammatory lesion count of 12, improvement of 7 in the treatment group and 3 in the placebo group, with a power of 0.87, SD of 3.25 and alpha level of 0.05. The HiSCR will be a secondary endpoint (reduction of inflammatory lesions by 50% with no increase in fistulas or abscesses). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05997277
Study type Interventional
Source Beth Israel Deaconess Medical Center
Contact Martina Porter, MD
Phone 617-667-5834
Email mporter3@gmail.com
Status Recruiting
Phase Phase 2
Start date November 30, 2023
Completion date December 31, 2026
View Details
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