Deucravacitinib in the Treatment of Cicatricial Alopecias
This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants will be enrolled: 10 Central Centrifugal Cicatricial Alopecia (CCCA) and 10 Frontal Fibrosing Alopecia (FFA). The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS). At the Baseline/Day 0 visit, participants will initiate treatment with deucravacitinib. All participants will receive deucravacitinib 12mg once-daily for 48 weeks. The treatment period will conclude at week 48.
• Participants of any gender, age 18 years or older, at the time of informed consent at Screening
• Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
• Participant self-reports a history of at least 6 months of moderate-to-severe CA (FFA or CCCA). Diagnosis will be made clinically, and severity assessed with according to the FFASI32 ≥30 and/or CHLG ≥3.
• Participant has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening or within the last 12 months.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of \<1%, during the intervention period and for at least 28 days after the last dose of study intervention. And if a WOCBP, must have a negative highly sensitive serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline performed before the first dose of study intervention.
• Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.