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
- 22
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
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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)