Deucravacitinib in the Treatment of Cicatricial Alopecias

NCT07508488 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY-25-01566
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Central Centrifugal Cicatricial Alopecia; Frontal Fibrosing Alopecia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (20)

• Changes in IFNγ in CA scalp

  Week 24 to Week 48

• Changes in CCL5 in CA scalp

  Week 24 to Week 48

• Changes in CXCL9 in CA scalp

  Week 24 to Week 48

• Changes in CXCL10 in CA scalp

  Week 24 to Week 48

• Changes in TGFB1/2 in CA scalp

  Week 24 to Week 48

Study Arms (2)

Central Centrifugal Cicatricial Alopecia

EXPERIMENTAL

Contains individuals diagnosed with Central Centrifugal Cicatricial Alopecia.

Drug: Deucravacitinib

Frontal Fibrosing Alopecia

EXPERIMENTAL

Contains individuals diagnosed with Frontal Fibrosing Alopecia.

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

6mg twice-daily oral treatment for 48 weeks.

Central Centrifugal Cicatricial Alopecia; Frontal Fibrosing Alopecia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

deucravacitinib

Study Officials

• Benjamin Ungar, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giselle Singer

CONTACT

2122413288; giselle.singer@mssm.edu

Sharlene Martin, MPH

CONTACT

sharlene.martin@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, open label

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 2, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)