A Pilot Study Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo in the Treatment of Moderate-to-severe Hidradenitis Suppurativa (HS).
Overview
- Phase
- Phase 2
- Intervention
- Deucravacitinib
- Conditions
- Hidradenitis Suppurativa
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.
- Status
- Terminated
- Last Updated
- 12 months ago
Overview
Brief 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.
Detailed 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).
Investigators
Alexa B Kimball
Professor of Dermatology
Beth Israel Deaconess Medical Center
Eligibility Criteria
Inclusion Criteria
- •• Male or Female at least 18 -70 years of age
- •Able to provide informed consent
- •Have at least 5 abscesses and/or inflammatory nodule (AN) count at baseline visits
- •Have HS lesions in 2 distinct anatomical areas
- •Women of Childbearing potential must have a negative serum urine pregnancy test at screening and a negative urine pregnancy test at baseline -- prior to administration of the first dose of study medication
- •Women of childbearing potential must be willing to continue a highly effective method of birth control throughout the study (oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant).
- •Tuberculosis Screening
- •Negative IGRA screening for tuberculosis within 3 months prior to screening, OR
- •If a positive history of latent tuberculosis:
- •Currently receiving treatment for latent TB per standard of care (with at least 4 weeks of treatment prior to baseline visit)
Exclusion Criteria
- •• Any other active skin disease that in the opinion of the investigator would interfere with the assessment of HS
- •Have greater than 20 draining fistula at baseline
- •Receipt of non-biologic treatments for HS within 4 weeks prior to baseline other than antibiotics or hormonal therapy
- •Receipt of TNF agents (i.e. Infliximab, adalimumab) or other biologics within 6 weeks prior to baseline
- •Receipt of new hormonal therapy for HS within 3 weeks prior to baseline
- •Receipt of oral antibiotics within 3 weeks prior to baseline.
- •o NOTE: subjects on concomitant antibiotics with a stable dose for 4 weeks prior to baseline visit may be included in the study. Only 25% of total enrollment may be on concomitant antibiotics.
- •Receipt of intralesional kenalog injections within 2 weeks prior to baseline
- •Receipt of topical steroids or topical antibiotics for HS for 2 weeks prior to baseline
- •o NOTE: subjects may continue topical washes (benzoyl peroxide, chlorhexidine, zinc pyrithione, dilute bleach)
Arms & Interventions
Deucravacitinib - Study Drug
Deucravacitinib group: 6 mg po bid x 16 weeks
Intervention: Deucravacitinib
Placebo
Placebo group: 1 tablet po bid x 16 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.
Time Frame: Baseline and Week 16
We will assess the average change in inflammatory lesion count per subject following 16 weeks of treatment as compared to baseline. Inflammatory lesions are defined as inflammatory nodules or abscesses.
Secondary Outcomes
- Changes in Hurley Stage scores at weeks 4, 8, 12, and 16 compared to baseline.(Baseline, weeks 4, 8, 12, and 16)
- The population treatment effect on proportion of participants with Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16 for the active treatment group relative to placebo without regard to IP compliance(Baseline and Week 16)
- Changes in IHS4 scores at weeks 4, 8, 12, and 16 compared to baseline.(Baseline, weeks 4, 8, 12, and 16)
- Changes in Dermatology Life Quality Index (DLQI) scores at weeks 4, 8, 12, and 16 compared to baseline.(Baseline, weeks 4, 8, 12, and 16)
- Changes in Visual Analogue Scale (VAS) pain scores at weeks 4, 8, 12, and 16 compared to baseline.(Baseline, weeks 4, 8, 12, and 16)