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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Delgocitinib
  twice-daily topical 2% cream

Первичные конечные точки

• Changes in IFNγ in CA scalp in delgocitinib-treated patients [Срок оценки: Baseline to Week 36]
• Changes in CCL5 in CA scalp in delgocitinib-treated patients [Срок оценки: Baseline to Week 36]
• Changes CXCL9 markers in CA scalp in delgocitinib-treated patients [Срок оценки: Baseline to Week 36]
• Changes in CXCL10 in CA scalp in delgocitinib-treated patients [Срок оценки: Baseline to Week 36]

Вторичные конечные точки (12)

• Changes in IFNγ in CA scalp in delgocitinib-treated patients [Срок оценки: Week 36 to Week 48]
• Changes in CCL5 in CA scalp in delgocitinib-treated patients [Срок оценки: Week 36 to Week 48]
• Changes in CXCL9 in CA scalp in delgocitinib-treated patients [Срок оценки: Week 36 to Week 48]
• Changes in Th1 markersCXCL10in CA scalp in delgocitinib-treated patients [Срок оценки: Week 36 to Week 48]
• Changes in TGFB1/2 [Срок оценки: Baseline to Week 36; Baseline to Week 48]
• Changes in vimentin [Срок оценки: Baseline to Week 36; Baseline to Week 48]
• Changes in fibronectin [Срок оценки: Baseline to Week 36; Baseline to Week 48]
• Changes in CTGF [Срок оценки: Baseline to Week 36; Baseline to Week 48]
• Change in Central Hair Loss Grade (CHLG) [Срок оценки: Baseline to Week 24; Baseline to Week 36; Baseline to Week 48]
• Change in Lichen Planopilaris Activity Index (LPPAI) [Срок оценки: 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 [Срок оценки: Baseline to Week 48; Week 24 to Week 48]
• Change in Dermatology Quality of Life Index (DLQI) [Срок оценки: Baseline to Week 24, Baseline to Week 36, Baseline to Week 48]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT07487948 · STUDY-26-00103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗