Actively Recruiting
Deucravacitinib in the Treatment of Cicatricial Alopecias
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating deucravacitinib in adults with two types of scarring hair loss: Central Centrifugal Cicatricial Alopecia (CCCA) and Frontal Fibrosing Alopecia (FFA). This phase 2, open-label study involves about 20 participants to assess the effects of this treatment over 48 weeks. The study is conducted at the Icahn School of Medicine at Mount Sinai and aims to understand changes in specific biological markers in affected scalp areas. All participants receive deucravacitinib orally at a dose of 12 mg once daily for 48 weeks, starting from the baseline visit. There are two groups based on diagnosis: one with CCCA and one with FFA. The treatment phase lasts for the full 48 weeks with no placebo or comparison group, allowing researchers to monitor the treatment's impact over time. Participants will be involved in regular study visits to assess changes in various immune and fibrotic markers in scalp tissue from baseline through week 48. Researchers will also measure clinical outcomes like hair loss severity, quality of life, itch severity, and hair count characteristics. Safety and adherence are monitored throughout, and the primary results focus on changes in inflammatory and fibrotic markers by week 24, with further assessments up to week 48.
CONDITIONS
Brief Title
Deucravacitinib in the Treatment of Cicatricial Alopecias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any gender, aged 18 years or older at screening
- Willing and able to follow the study visit schedule and protocol requirements
- History of at least 6 months of moderate-to-severe cicatricial alopecia (FFA or CCCA) diagnosed clinically
- Negative Tuberculin PPD or QuantiFERON TB-Gold test within the last 12 months
- Female participants must not be pregnant or breastfeeding; women of childbearing potential must use effective contraception and have negative pregnancy tests
- Generally in good overall health based on medical history, physical exam, and lab tests
You will not qualify if you...
- Hair loss cause is unclear or due to other reasons like pregnancy, drug-induced, telogen effluvium, or advanced androgenetic alopecia
- History of cicatricial alopecia longer than 5 years, severe fibrosing disease, or very rapid hair loss at screening
- Moderate to severe scalp keloids
- Other scalp diseases affecting assessment such as psoriasis or dermatitis
- Pregnant or breastfeeding
- Participation in other investigational drug studies within 4 weeks or 5 half-lives prior to entry
- Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis)
- Psychiatric conditions preventing participation
- Severe or uncontrolled medical conditions that increase risk or interfere with study
- History of thromboembolic events or inherited coagulopathies
- Current or past malignancies except certain treated skin or cervical cancers
- History of lymphoproliferative disorders or signs of lymphatic disease
- History of disseminated herpes infections
- Recent systemic infection requiring hospitalization or treatment
- Active infections requiring treatment within 4 weeks or skin infection within 1 week
- Upcoming or needed surgery during study
- Active hepatitis B or C, HIV infection
- Significant lab abnormalities affecting study data
- History of alcohol or substance abuse within 1 year
- Live vaccine within 6 weeks prior to screening
- Allergic reactions to study drug components
- Recent use of systemic immunosuppressants or other specific medications within defined timeframes
- Previous use of TYK2 inhibitors
- Recent use of topical corticosteroids or related drugs
- Recent treatment with biological drugs
- Positive or indeterminable tuberculosis test results or prior TB treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive 6mg of Deucravacitinib orally twice daily for 48 weeks to treat cicatricial alopecia.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Giselle Singer
S
Sharlene Martin, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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