A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Adult Patients of African Descent With Biopsy-proven Central Centrifugal Cicatricial Alopecia (CCCA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Change from Baseline in Investigator Global Assessment Score at Month 12
研究概览
简要总结
This study evaluated the safety and efficacy of baricitinib 4 mg daily in adults of African descent with biopsy-proven central centrifugal cicatricial alopecia, a scarring alopecia for which no FDA-approved treatment exists. Participants received open-label baricitinib for 52 weeks at four sites in the United States. Scalp hair loss was assessed by the Investigator Global Assessment at baseline and by the Investigator Re-Assessment Score at each post-baseline visit, with patient-reported quality of life and scalp symptom measures collected in parallel.
详细描述
Single-arm, open-label, Phase 2 study conducted in three periods: a screening period of approximately 4 weeks, a 52-week treatment period from Day 1 through Day 365, and a post-treatment follow-up period of approximately 4 weeks. Participants attended a screening visit, eight in-office visits and five safety follow-up telephone contacts. Investigational product was dispensed at Visits 2, 4, 6, 8 and 10 and collected at each subsequent visit for accountability. Efficacy was assessed by direct clinical examination supported by standardized clinical photography. Safety assessments included vital signs, physical assessment, laboratory analysis, the Columbia-Suicide Severity Rating Scale and adverse event collection at every contact. Twenty-seven participants received at least one dose and 17 completed the Day 365 visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age at the time of informed consent.
- •Of African descent.
- •Biopsy-proven central centrifugal cicatricial alopecia with no other cause of hair loss.
- •Agrees to use no other medication to treat central centrifugal cicatricial alopecia for the duration of the study.
- •Women of childbearing potential must use highly effective contraception during the intervention period and for 28 days after the last dose, and must have negative pregnancy tests at screening and at baseline.
- •In otherwise good general health by medical history, physical examination and laboratory testing.
排除标准
- •Pregnant or breastfeeding.
- •Any other form of alopecia, or any concomitant scalp or skin condition that would interfere with evaluation of study medication.
- •Active systemic disease that may cause hair loss.
- •Intralesional corticosteroids, oral JAK inhibitors, or any other treatment for central centrifugal cicatricial alopecia within 4 weeks of baseline.
- •Systemic immunosuppressive therapy within 8 weeks of baseline, or other non-biologic systemic agents within 4 weeks of baseline.
- •Participation in another interventional study within 4 weeks, or previous treatment with baricitinib.
- •Active tuberculosis, inadequately treated latent tuberculosis, hepatitis B, hepatitis C, or HIV infection.
- •Current or recent serious infection, or a history of recurrent eczema herpeticum.
- •Screening laboratory values outside protocol-specified hematologic, hepatic or renal limits.
- •Renal impairment.
- •History of venous thromboembolism or high risk for venous thromboembolism.
- •Myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Class III or IV heart failure within 12 weeks of screening.
- •History of lymphoproliferative disease, active malignancy, or malignancy in remission for less than 5 years.
- •Hypersensitivity to any component of study drug.
- •Live vaccine within 12 weeks of baseline or anticipated during the study.
- •Unable or unwilling to comply with study procedures for the duration of the study.
- •Investigator site personnel directly affiliated with this study, or their immediate family.
研究组 & 干预措施
Baricitinib 4 mg daily
Participants received baricitinib 2 mg orally twice daily, for a total daily dose of 4 mg, for 52 weeks.
干预措施: Baricitinib (Drug)
结局指标
主要结局
Change from Baseline in Investigator Global Assessment Score at Month 12
时间窗: Baseline and Month 12
The Investigator Global Assessment is a single-item observer-rated scale of scalp hair loss scored from 0 to 4, where 0 is none and 4 is very severe. One score is recorded per participant per timepoint. Change from baseline is the Month 12 score minus the baseline score, reported in units on a scale. A negative value indicates improvement.
次要结局
- Investigator Re-Assessment Score(Months 1, 3, 6, 9 and 12)
- Change from Baseline in Investigator Global Assessment Score at Months 1, 3, 6 and 9(Baseline and Months 1, 3, 6 and 9)
- Change from Baseline in Psychological Quality of Life Total Score(Baseline and Months 1, 3, 6, 9 and 12)
- Change from Baseline in Patient Subjective Measurements Total Score(Baseline and Months 1, 3, 6, 9 and 12)
- Number of Participants With at Least One Dermatoscopic Feature of Central Centrifugal Cicatricial Alopecia Present(Months 1, 3, 6, 9 and 12)