A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 27
- 主要终点
- Percentage of subjects achieving an absolute SALT score of 20 or less
研究概览
简要总结
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
详细描述
The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Written informed consent has been obtained.
- Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
- SALT score of 50 or more at both Screening and Baseline.
排除标准
- Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
- Treatment with biologics within 6 months prior to Screening.
- Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
- History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
研究组 & 干预措施
Placebo
Participants in this arm will receive matching placebo administered orally BID during the 24-week double-blind treatment period and then receive deuruxolitinib 8 mg administered orally BID up to 52 weeks.
干预措施: Placebo (Drug)
Deuruxolitinib 8 mg
Participants in this arm will receive deuruxolitinib 8 mg administered orally twice daily (BID) during the 24-week double-blind treatment period and continue to receive deuruxolitinib 8 mg administered orally BID up to 52 weeks
干预措施: Deuruxolitinib (Drug)
结局指标
主要结局
Percentage of subjects achieving an absolute SALT score of 20 or less
时间窗: Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
次要结局
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale(Week 24)
- Percentage of subjects achieving an absolute SALT score of 20 or less(Weeks 12, 16, and 20)
- Relative change in SALT scores from baseline(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I(Weeks 12, 16, 20, and 24)
- Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I(Weeks 12, 16, 20, and 24)
- Change from baseline in CGI-S(Weeks 12, 16, 20, and 24)
- Change from baseline in PGI-S(Weeks 12, 16, 20, and 24)
- Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline(Weeks 12 and 24)
- Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline(Weeks 12 and 24)
- Percentage of subjects achieving an absolute SALT score of 20 or less(Weeks 4 and 8)
- Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score(Weeks 12 and 24)
- Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score(Weeks 12 and 24)
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale(Weeks 12, 16, and 20)
- Change from baseline in SPRO scale(Weeks 12, 16, 20, and 24)
- Percentage of subjects achieving an absolute SALT score of 10 or less(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of subjects achieving a 2-point or greater improvement from baseline in SPRO scale(Weeks 12, 16, 20, and 24)
- Change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale(Weeks 12, 16, 20, and 24)
- Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)(Week 24)
- Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS)(Week 24)
研究者
研究点 (27)
标识符
- NCT 编号
- NCT07617597
- 其他研究编号
- CTP-543-25-01JP, jRCT2031260062
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否