A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Systemic Exposure of Cerdulatinib Gel, 0.37% in Adults With Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Laboratory Values
研究概览
简要总结
This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% BSA involvement.
- •Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- •Capable of giving informed consent
排除标准
- •Diagnosis of segmental vitiligo
- •Subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study
- •Use of any prohibited medication within the indicated period before the first dose of study drug
- •Pregnant or lactating females
- •Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 8 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo
- •The subject has received an investigational product within the following time period prior to the first dosing day: 4 weeks or 5 half-lives (whichever is longer).
- •Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory test value abnormality that will affect the health of the subject or interfere with interpretation of the results
- •History of sensitivity to the study drug, or components thereof or a history of drug or other allergy that contraindicates the subject's participation in the study;
研究组 & 干预措施
Cerdulatinib 0.37% gel
Cerdulatinib 0.37% gel applied topically twice daily
干预措施: Cerdulatinib 0.37% gel (Drug)
Vehicle gel
Vehicle gel applied topically twice daily
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Laboratory Values
时间窗: Baseline through Week 7
Clinically significant abnormal lab values
Adverse Events
时间窗: Baseline through Week 7
Frequency, severity, and duration of adverse events
Vital signs
时间窗: Baseline through Week 7
Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)
Local Tolerability Scale Score
时间窗: Baseline, Week 2, Week 4, Week 6, and Week 7
Assessment of local site investigational product administration
次要结局
- Concentration of cerdulatinib(Days 1, 15, 29 and 43)
- Blister fluid biomarker concentration(Baseline and Week 6)