Phase
Condition
Hidradenitis Suppurativa
Rosacea
Scalp Disorders
Treatment
Deucravacitinib
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
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
Study Description
Connect with a study center
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
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