A Pilot Study Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo in the Treatment of Moderate-to-severe Hidradenitis Suppurativa (HS).

2023P000400

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.

2023-11-30

2025-12-31

2026-12-31

Recruiting

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-02-06