Deucravacitinib in the Treatment of Cicatricial Alopecias
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
Participant has a history of CA for > 5 years since the disease onset, severe fibrosing disease, or very rapid hair loss at screening.
Participant has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening. Deucravacitinib in the Treatment of Cicatricial Alopecias October 23, 2025.
Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
Trial design
Treatments tested in this trial
- Deucravacitinib
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov