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

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Deucravacitinib

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)

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

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)

• Receipt of opioid analgesics or other concomitant analgesics for HS pain within 72 hours prior to the baseline visit

o Concomitant use of non-opioid analgesics for treatment of chronic non-HS pain is allowed as long as the dose has been stable for 14 days prior to baseline and expected to remain constant throughout the study

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

• Currently has a malignancy or a history of a malignancy within 5 years before screen (except successfully treated non-melanoma skin cancer or cervical carcinoma in situ)

• History of an ongoing, chronic or recurrent infectious disease

• Are currently pregnant, breastfeeding, or planning to get pregnant during the study

o male participants who are actively trying to conceive with their partner are also excluded.

• Previous hypersensitivity reaction to deucravacitinib or to any of the components

• Known allergy to tetracycline antibiotics

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

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