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临床试验 NCT07508488 针对中央离心性瘢痕性脱发，额部纤维化性脱发目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Deucravacitinib in the Treatment of Cicatricial Alopecias II期 20 开放性试验
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临床试验NCT07508488旨在研究治疗，主要针对中央离心性瘢痕性脱发，额部纤维化性脱发。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月1日开始，预计招募20名患者。该研究由Icahn School of Medicine at Mount Sinai主导，计划于2027年1月21日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年4月2日。
简要概括
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 ...显示更多
官方标题
Deucravacitinib in the Treatment of Cicatricial Alopecias
疾病
中央离心性瘢痕性脱发额部纤维化性脱发其他研究标识符
- STUDY-25-01566
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Central Centrifugal Cicatricial Alopecia Contains individuals diagnosed with Central Centrifugal Cicatricial Alopecia. | Deucravacitinib 12mg once-daily oral treatment for 48 weeks. |
实验性Frontal Fibrosing Alopecia Contains individuals diagnosed with Frontal Fibrosing Alopecia. | Deucravacitinib 12mg once-daily oral treatment for 48 weeks. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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.
- 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.
Icahn School of Medicine at Mount Sinai百时美施贵宝研究责任方
Benjamin Ungar, 主要研究者, Assistant Professor, Icahn School of Medicine at Mount Sinai
研究中心联系人
联系人: Sharlene Martin, MPH, 2122413288, [email protected]
1 位于 1 个国家/地区的研究中心
New York
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States
Giselle Singer, 联系人, 212-241-3288, [email protected]
Benjamin Ungar, 主要研究者