Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris

A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris

This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen planopilaris (LPP) or central centrifugal cicatricial alopecia (CCCA) over a 48-week treatment period. Approximately 30 participants will be enrolled: 15 CCCA and 15 LPP. The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS).

Study Overview

• Status: Recruiting
• Conditions: Central Centrifugal Cicatricial Alopecia; Lichen Planopilaris
• Intervention / Treatment: Drug: Delgocitinib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sharlene Martin, MPH; Phone Number: 2122413288; 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 CA (LPP or CCCA). Diagnosis will be made clinically (according to the LPPAI10, and/or CHLG11) and/or histopathologically.
• Participants who are females of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 28 days after the last dose of study drug. Acceptable methods of birth control include intrauterine device (IUD) oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, Participants must have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
• Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.

Exclusion Criteria:

• Participants 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 ≥ 4 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.
• 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 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 Baseline.
• Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
• Have an active history of alcohol or substance abuse within 1 year prior to Day 0.
• Participant has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints, at determined by the PI.
• 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.
• 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.

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: Centrifugal Cicatricial Alopecia (CCCA); Individuals in the study diagnosed with CCCA are in this arm.	Drug: Delgocitinib; twice-daily topical 2% cream
Experimental: Lichen Planopilaris (LPP); Individuals in the study diagnosed with LPP are in this arm.	Drug: Delgocitinib; twice-daily topical 2% cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IFNγ in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients	Baseline to Week 36
Changes in CCL5 in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients	Baseline to Week 36
Changes CXCL9 markers in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients	Baseline to Week 36
Changes in CXCL10 in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients	Baseline to Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IFNγ in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48	Week 36 to Week 48
Changes in CCL5 in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48	Week 36 to Week 48
Changes in CXCL9 in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48	Week 36 to Week 48
Changes in Th1 markersCXCL10in CA scalp in delgocitinib-treated patients	Changes in Th1 markers in CA scalp from baseline to week 48 and from week 36 to week 48	Week 36 to Week 48
Changes in TGFB1/2	Changes in biomarkers of fibrosis at weeks 36 and at weeks 48	Baseline to Week 36; Baseline to Week 48
Changes in vimentin	Changes in biomarkers of fibrosis at weeks 36 and at weeks 48	Baseline to Week 36; Baseline to Week 48
Changes in fibronectin	Changes in biomarkers of fibrosis at weeks 36 and at weeks 48	Baseline to Week 36; Baseline to Week 48
Changes in CTGF	Changes in biomarkers of fibrosis at weeks 36 and at weeks 48	Baseline to Week 36; Baseline to Week 48
Change in Central Hair Loss Grade (CHLG)	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 36; Baseline to Week 48
Change in Lichen Planopilaris Activity Index (LPPAI)	The Lichen Planopilaris Activity Index is a standardized validated quantitative measure of disease activity. LPPAI score (0-10) is calculated as follows: (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are graded on a 4-point scale with 0 = absent, 1 = mild, 2 = moderate, and 3 =severe. Clinical progression and a positive hair pull test are graded 1=yes; 0=no.	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Molecular cutaneous phenotype of CCCA and LPP by molecular studies in scalp tissues acquired via biopsies	An Analysis of Covariance will be used to analyze the changes induced by Delgocitinib in CCL5 (a surrogate for IFNγ activity) and biomarkers of fibrosis expression in CA scalp from baseline to week 48 and from week 24 to week 48.	Baseline to Week 48; Week 24 to Week 48
Change in Dermatology Quality of Life Index (DLQI)	Full score on scale from 0 to 30, with higher indicating higher impact on quality of life.	Baseline to Week 24, Baseline to Week 36, Baseline to Week 48
Change in hair count per cm2	Change in number of hairs present in a 1cm2 area	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in sum of hair width per cm2	Change in total hair diameter in a 1cm2 area	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in terminal:vellus ratio	Change in the ratio of thick pigmented long hair to fine-barely visible hairs	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in average hairs per follicular unit	Change in average number of hairs growing out of each pore	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in average hair width	Change in average width of each individual hair	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in follicular units per cm2	Change in hair density in a 1cm2 area	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in inter-follicular mean distance	Change in average gap between hairs	Baseline to Week 24; Baseline to Week 36; Baseline to Week 48
Change in Peak Pruritus Numerical Rating Scale (PP-NRS)	The score ranges from 0 - 10 with 0 representing no itch and 10 representing worse possible itch.	Baseline to Week 24, Baseline to Week 36, Baseline to Week 48

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: LEO Pharma
• Investigators: Principal Investigator: Benjamin Ungar, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 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: Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus; delgocitinib
• Other Study ID Numbers: STUDY-26-00103

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