NCT00866359已完成2 期
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease
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
- 111
- 试验地点
- 7
- 主要终点
- Number of Oral Ulcers at Day 85
研究概览
简要总结
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.
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
- •Diagnosis of Behçet Disease. At the time of diagnosis, subjects must meet the international study group criteria for Behçet Disease
- •Females of childbearing potential (FCBP) must have negative pregnancy tests and agree to use two forms of contraception throughout the study.
- •Males must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP
- •Laboratory criteria: Hgb ≥ 9 g/dL, WBC count ≥ 3000 /microL and ≤14,000/microL, platelet count ≥ 100,000 /microL,, serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L), total bilirubin ≤ 2.0 mg/dL, AST and ALT ≤ 1.5 X ULN
- •Two or more oral ulcers over the 28 day period before screening, with or without current treatment
- •Two or more oral ulcers at the time of randomization (Visit 2, Baseline)
排除标准
- •Pregnant or breast feeding
- •Any condition which places the subject at risk
- •Systemic fungal infection
- •History of TB infection within 3 years
- •History of recurrent bacterial infection
- •Mycobacterium TB as indicated by a positive PPD skin test
- •History of incompletely treated Mycobacterium tuberculosis
- •Clinically significant chest x-ray abnormality at screening.
- •Clinically significant ECG abnormality at screening
- •History of HIV infection
- •History of congenital or acquired immunodeficiency
- •Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
- •Antibodies to Hepatitis C at screening
- •History of malignancy (except for treated basal-cell skin carcinomas > 3 years prior to screening)
- •Any active major organ involvement of Behçet Disease
- •Use of concomitant immune modulating therapy or topical corticosteroids.
- •Use of ocular corticosteroids
- •Use of any investigational medication within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer)
研究组 & 干预措施
A. Apremilast
Active Comparator
干预措施: Apremilast (CC-10004) (Drug)
B. Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Oral Ulcers at Day 85
时间窗: Day 85
The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).
次要结局
- Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85(Day 85)
- Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85(Day 85)
- Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)(Baseline and Day 85)
- Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85(Day 1 to Day 85 or to early termination visit)
- Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase(Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase)
- Number of New Manifestations of Behçet's Disease or Flare During the Placebo Controlled Treatment Phase(Day 1 to Day 85)
- Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85(Baseline to Day 85)
- Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85(Day 1 to Day 85)
- Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85(Day 1 to Day 85)
- Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85(Day 1 to Day 85)
- Number of Oral Ulcers at Day 169(Day 169)
- Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169(Day 169)
- Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169(Day 1 to Day 169)
- Behçet's Disease (BD) Current Activity Index Form Score at Day 169(Day 169)
- Number of New Manifestations of Behçet's Disease or Flare That Were Not Present at Day 1(Day 1 to Day 169)
- Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197(Day 197)
- Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197(Day 1 to Day 197)
- Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197(Day 1 to Day 197)
- Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase(Day 1 to Day 197; maximum exposure was 25.1 weeks)
- Number of Oral Ulcers at Day 197(Day 197)
研究者
研究点 (7)
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