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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05997277
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Deucravacitinib — DRUG
    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 — DRUG
    Placebo will consist of a tablet (0mg) and will be administered orally BID for 16weeks.

Study Details

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.

Key Dates

Start date
Nov 30, 2023
Status verified
May 2026
Primary completion
Feb 25, 2025
Completion
Apr 10, 2025

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deucravacitinib - Study Drug
    Deucravacitinib group: 6 mg po bid x 16 weeks
  • Placebo Comparator: Placebo
    Placebo group: 1 tablet po bid x 16 weeks

Primary Outcome Measure

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. [ Time Frame: Baseline and Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

Related coverage on Hipa.ai

Find similar trials in Boston, MA

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Beth Israel Deaconess Medical Center· Boston, MA

Related Studies