Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Adjusted Annualized Relapse Rate Between Baseline and Week 52
研究概览
简要总结
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:
- •Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
- •Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
排除标准
- •Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- •History of malignancy
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity
- •History of abnormal laboratory results based on investigator judgment
- •History of human immunodeficiency virus (HIV) or other immunodeficient conditions
- •History of drug or alcohol abuse within the 2 years prior to randomization
- •An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
- •Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
- •Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
- •Exposure to varicella zoster virus within 21 days before Screening.
- •Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10^9/L, Lymphocytes ≤1.0 × 10^9/L, Neutrophils ≤1.5 × 10^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
150 mg DAC HYP
Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
Placebo
Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks.
干预措施: Placebo (Drug)
300 mg DAC HYP
Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
结局指标
主要结局
Adjusted Annualized Relapse Rate Between Baseline and Week 52
时间窗: Baseline through Week 52
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
次要结局
- Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24(Week 8 through Week 24)
- Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52(Week 52)
- Proportion of Participants Who Relapsed at Week 52(Week 52)
- Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52(Baseline and Week 52)