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.
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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
Deucravacitinib is a stable deuterium-containing compound (where deuterium is a stable, nonradioactive isotope of hydrogen) and a potent, highly selective small molecule inhibitor of TYK2. Deucravacitinib has a unique mode of binding that provides the high selectivity over the other members of the JAK family of nonreceptor tyrosine kinases. 1 active oral tablet (6mg) in the morning and evening for 16weeks.
Placebo will consist of a tablet (0mg) and will be administered orally BID for 16weeks.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Median Change From Baseline in Number of Inflammatory Lesion Counts (Including Combined Counts of Inflammatory Nodules (N) and Abscesses (A)/AN Count) at Week 16.
Median change in number of inflammatory lesion count per subject following 16 weeks of treatment as compared to baseline. Inflammatory lesions are defined as inflammatory nodules or abscesses. Increase is interpreted as an additional single standard unit of the disease compared to baseline (1 nodule or abscess = 1 unit)
Time frame: Baseline and Week 16
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