A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 5
- 试验地点
- 19
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
详细描述
Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;
Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
- •Good health as assessed by Investigator
- •DLE for at least 16 weeks prior to screening and consistent histological findings.
- •Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
- •Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
- •Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
- •Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
- •Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.
排除标准
- •Significant illnesses as determined by physician.
- •History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
- •Systolic blood pressure < 95 or > 150 mm Hg
- •Diastolic blood pressure > 90 mm Hg.
- •Pregnancy or breast feeding.
- •Other dermatological conditions that would interfere with CLASI Activity Score assessments.
- •History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
- •Clinically significant abnormality on chest X-ray.
- •Participation in multiple CC-930 cohorts.
- •History of thrombolytic event.
- •Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
- •Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
- •Diagnosis of SLE.
- •Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
- •History of seizures, chorea or psychosis.
- •Presence or history of persistent proteinuria or urinary cellular casts.
- •Prohibited prior or concomitant medications.
研究组 & 干预措施
Cohort 4
100 mg twice daily for 6 weeks (8 active/2 control)
干预措施: CC-930 (Drug)
Cohort 1
25 mg daily for 4 weeks (8 active/2 control)
干预措施: CC-930 (Drug)
Cohort 1
25 mg daily for 4 weeks (8 active/2 control)
干预措施: Placebo (Drug)
Cohort 2
50 mg once daily for 4 weeks (8 active/2 control)
干预措施: CC-930 (Drug)
Cohort 2
50 mg once daily for 4 weeks (8 active/2 control)
干预措施: Placebo (Drug)
Cohort 3
100 mg daily for 6 weeks (8 active/2 control)
干预措施: CC-930 (Drug)
Cohort 3
100 mg daily for 6 weeks (8 active/2 control)
干预措施: Placebo (Drug)
Cohort 4
100 mg twice daily for 6 weeks (8 active/2 control)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: 4 to 6 weeks
次要结局
- To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.(18 months)