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.

Study Overview

• Status: Recruiting
• Conditions: Frontal Fibrosing Alopecia; Central Centrifugal Cicatricial Alopecia
• Intervention / Treatment: Drug: Deucravacitinib

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Giselle Singer; Phone Number: 2122413288; Email: giselle.singer@mssm.edu
• Study Contact Backup: Name: Sharlene Martin, MPH; Email: sharlene.martin@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School Of Medicine At Mount Sinai
      • Principal Investigator: Benjamin Ungar
      • Contact: Giselle Singer; Phone Number: 212-241-3288; Email: giselle.singer@mssm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).
• Participant is pregnant or breastfeeding.
• Participation in other studies involving investigational drug(s) within 4 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation (de novo patients only).
• Active systemic diseases that may cause hair loss (e.g., systemic lupus erythematosus, thyroiditis, systemic sclerosis, etc.).
• Any Psychiatric condition in the opinion of the investigator precludes participation in the study.
• Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the participant is inappropriate for entry into this study, or unwilling/unable to comply with STUDY PROCEDURES.
• History of thromboembolic events including DVT and PE or history of inherited coagulopathies.
• Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
• History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
• History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 0.
• Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 0 or superficial skin infection within 1 week prior to Day 0. Deucravacitinib in the Treatment of Cicatricial Alopecias October 23, 2025.
• Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
• Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening.
• Participant has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints, as determined by the PI.
• Have an active history of alcohol or substance abuse within 1 year prior to Day 0.
• Participant has received a live attenuated vaccine ≤ 6 weeks prior to study screening.
• History of adverse systemic or allergic reactions to components of study drug.
• Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, within 8 weeks prior to baseline visit.
• Use of other non-biologic systemic agent for CA, including, 5α-reductase inhibitors, hydroxychloroquine, or retinoids, within 4 weeks prior to baseline visit.
• Use of an intralesional corticosteroids or oral JAK inhibitor (tofacitinib, ruxolitinib, or any JAK1/TYK2 product) within 4 weeks prior to the baseline visit.
• Any previous use of a TYK2 inhibitor.
• Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus or cyclosporine within 1 week before the baseline visit.
• Participant has been previously treated with biological drugs in the last 12 weeks for other indications.
• Participants previously tested with a positive or indeterminable PPD or QFT result, including participants that completed standard tuberculosis therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Central Centrifugal Cicatricial Alopecia; Contains individuals diagnosed with Central Centrifugal Cicatricial Alopecia.	Drug: Deucravacitinib; 6mg twice-daily oral treatment for 48 weeks.
Experimental: Frontal Fibrosing Alopecia; Contains individuals diagnosed with Frontal Fibrosing Alopecia.	Drug: Deucravacitinib; 6mg twice-daily oral treatment for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IFNγ in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in CCL5 in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in CXCL9 in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in CXCL10 in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in TGFB1/2 in CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in vimentin in CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in fibronectin CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24
Changes in CTGF in CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IFNγ in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in CCL5 in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in CXCL9 in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in CXCL10 in CA scalp	Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in TGFB1/2 in CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in vimentin in CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in fibronectin CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Changes in CTGF in CA scalp	Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24	Week 24 to Week 48
Change in The Central Hair Loss Grade (CHLG)	Change in CHLG from baseline at week 24 and week 48. The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss, 1 - minimal central scalp hair loss, 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss).	Baseline to Week 24; Baseline to Week 48
Change in Frontal Fibrosing Alopecia Severity Index (FFASI)	Change in FFASI from baseline at week 24 and week 48. The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity.	Baseline to Week 24; Baseline to Week 48
Changes in mRNA Levels of CCL5 gene expression in skin biopsies	Evaluation of how the two skin conditions (CCCA and FFA) present themselves at the microscopic level. The skin samples will be obtained via biopsies. Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene	baseline and week 24
Change in Alopecia Areata Quality of Life Index (AA-QLI)	Change in Alopecia Areata Quality of Life Index (AA-QLI) in week 24 and week 48. The scores range from 0 - 30 with 0 representing no impact to quality of life and 30 representing extremely large impact.	Week 24 and Week 48
Change in Peak Pruritus Numerical Rating Scale (PP-NRS)	Change in Peak Pruritus Numerical Rating Scale (PP-NRS) at week 24 and week 48. The score ranges from 0 - 10 with 0 representing no itch and 10 representing worse possible itch.	Week 24 and Week 48
Change in hair count per cm2	Change in number of hairs present in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48	Baseline to Week 24; Baseline to Week 48
Change in sum of hair width per cm2	Change in total hair diameter in a 2 cm2 area between Baseline to Week 24 and Baseline to Week 48	Baseline to Week 24; Baseline to Week 48
Change in terminal:vellus ratio	Change in the ratio of thick pigmented long hair to fine-barely visible hairs between Baseline to Week 24 and Baseline to Week 48	Baseline to Week 24; Baseline to Week 48
Change in average hairs per follicular unit	Change in hair density in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48	Baseline to Week 24; Baseline to Week 48
Change in average hair width	Change in average width of each individual hair between Baseline to Week 24 and Baseline to Week 48	Baseline to Week 24; Baseline to Week 48
Change in follicular units per cm2	Change in hair density in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48	Baseline to Week 24; Baseline to Week 48
Change in inter-follicular mean distance	Change in average gap between hairs using a diagnotic tool called the HairMetrix diagnostic tool that can accurately measure the interfollicular distance between baseline to Week 24 and baseline to Week 48	Baseline to Week 24; Baseline to Week 48

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Benjamin Ungar, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: deucravacitinib
• Other Study ID Numbers: STUDY-25-01566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be analyzed and published as aggregate data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No