NCT07487948招募中2 期
A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in IFNγ in CA scalp in delgocitinib-treated patients
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
Centrifugal Cicatricial Alopecia (CCCA)
Experimental
Individuals in the study diagnosed with CCCA are in this arm.
干预措施: Delgocitinib (Drug)
Lichen Planopilaris (LPP)
Experimental
Individuals in the study diagnosed with LPP are in this arm.
干预措施: Delgocitinib (Drug)
结局指标
主要结局
Changes in IFNγ in CA scalp in delgocitinib-treated patients
时间窗: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in CCL5 in CA scalp in delgocitinib-treated patients
时间窗: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes CXCL9 markers in CA scalp in delgocitinib-treated patients
时间窗: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
Changes in CXCL10 in CA scalp in delgocitinib-treated patients
时间窗: Baseline to Week 36
Changes in Th1 markers in CA scalp from baseline to week 36 in delgocitinib-treated patients
次要结局
- Changes in IFNγ in CA scalp in delgocitinib-treated patients(Week 36 to Week 48)
- Changes in CCL5 in CA scalp in delgocitinib-treated patients(Week 36 to Week 48)
- Changes in CXCL9 in CA scalp in delgocitinib-treated patients(Week 36 to Week 48)
- Changes in Th1 markersCXCL10in CA scalp in delgocitinib-treated patients(Week 36 to Week 48)
- Changes in TGFB1/2(Baseline to Week 36; Baseline to Week 48)
- Changes in vimentin(Baseline to Week 36; Baseline to Week 48)
- Changes in fibronectin(Baseline to Week 36; Baseline to Week 48)
- Changes in CTGF(Baseline to Week 36; Baseline to Week 48)
- Change in Central Hair Loss Grade (CHLG)(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in Lichen Planopilaris Activity Index (LPPAI)(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(Baseline to Week 48; Week 24 to Week 48)
- Change in Dermatology Quality of Life Index (DLQI)(Baseline to Week 24, Baseline to Week 36, Baseline to Week 48)
- Change in hair count per cm2(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in sum of hair width per cm2(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in terminal:vellus ratio(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in average hairs per follicular unit(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in average hair width(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in follicular units per cm2(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in inter-follicular mean distance(Baseline to Week 24; Baseline to Week 36; Baseline to Week 48)
- Change in Peak Pruritus Numerical Rating Scale (PP-NRS)(Baseline to Week 24, Baseline to Week 36, Baseline to Week 48)
研究者
Benjamin Ungar
Assistant Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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