NCT01300208已完成2 期
A Phase 2, Pilot, Multicenter, Sequential, Ascending Dose Study to Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 48
- 试验地点
- 19
- 主要终点
- Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern
研究概览
简要总结
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for > 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determined by the Investigator)
- •Must, in the opinion of the Investigator, have active skin lesions of sufficient severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index Activity Score of ≥ 10)
- •All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of an ophthalmologic exam performed within 24 weeks of the Baseline Visit.
- •Must meet the following laboratory criteria:
- •White blood cell count ≥3000/mm3 (≥ 3.0 x 109/L) and < 14,000/mm3 (< 14 x 109/L)
- •Absolute neutrophil count (ANC) > 1500 cells/μL (1.5 x 109/L)
- •Platelet count ≥ 100,000/μL (≥ 100 x 109/L)
- •Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
- •Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT)
- •≤ 1.5 X upper limit of normal (ULN)
- •Total bilirubin < 2mg/dL
- •Hemoglobin > 11 g/dL Key Exclusion Criteria
- •Participation in multiple CC-11050 cohorts or previous exposure to CC-11050
- •Presence or history of SLE based on investigators' clinical evaluation where subject exhibits medically significant (as determined by the Investigator) LE-related pleuritis, pericarditis, neurologic, renal and/or other major SLE-related organ system involvement(SLE-related to SLE joint involvement is acceptable).
- •Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
- •Use of concomitant disease modifying anti-rheumatic drugs (DMARDs) with the exception of anti-malarials within 4 weeks of screening- Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
- •Use of immunosuppressives (eg, azathioprine, mycophenolate mofetil, methotrexate, etc.) within 4 weeks of screening
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Experimental
CC-11050 (50 milligrams twice per day and Placebo)
干预措施: CC-11050 (Drug)
Cohort 1
Experimental
CC-11050 (50 milligrams twice per day and Placebo)
干预措施: Placebo (Other)
Cohort 2
Experimental
CC-11050 (100 milligrams twice per day and Placebo)
干预措施: CC-11050 (Drug)
Cohort 2
Experimental
CC-11050 (100 milligrams twice per day and Placebo)
干预措施: Placebo (Other)
Cohort 3
Experimental
CC-11050 (200 milligrams twice per day and Placebo)
干预措施: CC-11050 (Drug)
Cohort 3
Experimental
CC-11050 (200 milligrams twice per day and Placebo)
干预措施: Placebo (Other)
结局指标
主要结局
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern
时间窗: Up to 21 weeks
次要结局
- Pharmacokinetics(Up to 21 weeks)
- To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment(12 weeks)
- Pharmacokinetics (PK)(Up to 21 weeks)
研究者
研究点 (19)
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