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
124 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
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.
CONDITIONS
Official 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 the time of informed consent
- Willing and able to follow study visits and protocol requirements
- Self-reported history of at least 6 months of moderate-to-severe cicatricial alopecia (FFA or CCCA) diagnosed clinically with severity scores according to FFASI32 30 and/or CHLG 3
- Negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test within 12 months before screening
- Female participants must not be pregnant or breastfeeding and must use highly effective contraception if of childbearing potential
- Overall good 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 causes like pregnancy, drug-induced, telogen effluvium, or advanced androgenetic alopecia
- History of cicatricial alopecia for more than 5 years, severe fibrosing disease, or very rapid hair loss at screening
- History of 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 or during this study
- Active systemic diseases causing hair loss like lupus, thyroiditis, systemic sclerosis
- Psychiatric conditions precluding study participation
- Severe or uncontrolled medical conditions affecting kidneys, liver, blood, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, psychiatric, immune, rheumatologic, or neurologic systems
- History of thromboembolic events or inherited coagulopathies
- Current or past malignancies except certain treated non-metastatic skin or cervical cancers
- History of lymphoproliferative disorders or lymphatic/lymphoid diseases
- History of disseminated or recurrent herpes infections
- Systemic infections requiring hospitalization or significant treatment within 6 months prior to Day 0
- Active infections needing treatment within 4 weeks before Day 0 or skin infections within 1 week before Day 0
- Scheduled surgery during the study or urgent surgical needs
- Active hepatitis B, C, or HIV infection
- Significant lab abnormalities affecting study data
- History of alcohol or substance abuse within 1 year prior to Day 0
- Live attenuated vaccine within 6 weeks before screening
- Allergic reactions to study drug components
- Use of systemic immunosuppressants within 8 weeks before baseline
- Use of other non-biologic systemic agents for cicatricial alopecia within 4 weeks before baseline
- Use of intralesional corticosteroids or oral JAK inhibitors within 4 weeks before baseline
- Prior use of a TYK2 inhibitor
- Use of topical corticosteroids or related treatments within 1 week before baseline
- Previous biological drug treatment within 12 weeks for other conditions
- Positive or indeterminable tuberculosis test history, including completed TB therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Sharlene Martin, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here