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

Last updated: March 19, 2025
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Hidradenitis Suppurativa

Rosacea

Scalp Disorders

Treatment

Deucravacitinib

Placebo

Clinical Study ID

NCT05997277
2023P000400
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 baselinevisits

  • Have HS lesions in 2 distinct anatomical areas

  • Women of Childbearing potential must have a negative serum urine pregnancy testat screening and a negative urine pregnancy test at baseline -- prior toadministration of the first dose of study medication

  • Women of childbearing potential must be willing to continue a highly effectivemethod of birth control throughout the study (oral, injected or implantedhormonal methods of contraception; placement of an intrauterine device orintrauterine system; barrier methods: condom or occlusive cap (diaphragm orcervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (ifavailable in their locale); male partner sterilization (the vasectomizedpartner should be the sole partner for that participant); true abstinence (whenthis is in line with the preferred and usual lifestyle of the participant).

  • Tuberculosis Screening

  • Negative IGRA screening for tuberculosis within 3 months prior toscreening, OR

  • If a positive history of latent tuberculosis:

  • Currently receiving treatment for latent TB per standard of care (with at least 4weeks of treatment prior to baseline visit)

  • Have documentation of having completed treatment within 5 years prior to baseline •Agree not to have a live vaccination during the study

Exclusion

Exclusion Criteria:

  • • Any other active skin disease that in the opinion of the investigator wouldinterfere 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 baselineother than antibiotics or hormonal therapy

  • Receipt of TNF agents (i.e. Infliximab, adalimumab) or other biologics within 6weeks 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 weeksprior to baseline visit may be included in the study. Only 25% of totalenrollment 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 tobaselineo NOTE: subjects may continue topical washes (benzoyl peroxide, chlorhexidine,zinc pyrithione, dilute bleach)

  • Receipt of opioid analgesics or other concomitant analgesics for HS pain within 72 hours prior to the baseline visito Concomitant use of non-opioid analgesics for treatment of chronic non-HS painis allowed as long as the dose has been stable for 14 days prior to baselineand expected to remain constant throughout the study

  • Any uncontrolled diagnosis or condition that in the opinion of the investigatorwill interfere with the assessments or the study.

  • Currently has a malignancy or a history of a malignancy within 5 years beforescreen (except successfully treated non-melanoma skin cancer or cervicalcarcinoma in situ)

  • History of an ongoing, chronic or recurrent infectious disease

  • Are currently pregnant, breastfeeding, or planning to get pregnant during thestudyo male participants who are actively trying to conceive with their partner arealso excluded.

  • Previous hypersensitivity reaction to deucravacitinib or to any of thecomponents

  • Known allergy to tetracycline antibiotics

  • Known infection with HIV, hepatitis B or hepatitis C at screening orrandomization. Patients who are Hepatitis B Core antibody and/or Hep B SurfaceAntigen positive will be excluded from this study. Patients who are Hepatitis Cab positive will also be excluded from this study.

  • Underlying condition (including, but not limited to metabolic, hematologic,renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious orgastrointestinal) which in the opinion of the investigator significantlyimmunocompromises the subject and/or places the subject at unacceptable riskfor receiving an immunomodulatory therapy

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Deucravacitinib
Phase: 2
Study Start date:
November 30, 2023
Estimated Completion Date:
December 31, 2026

Study 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).

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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