A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 419
- 试验地点
- 68
- 主要终点
- Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.
Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
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 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
- •RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
- •All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment
排除标准
- •A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
- •Previous history of clinically significant disease.
- •Plans to undergo elective major procedures/surgeries at any time during the study.
- •Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
- •RRMS subjects with any history of inadequate response to any approved interferon β preparation
- •History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
- •History or evidence of drug or alcohol abuse within 2 years prior to randomization
- •Note: Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: BIIB033 (Drug)
BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84.
干预措施: BIIB033 (Drug)
BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84.
干预措施: Avonex (Drug)
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: Avonex (Drug)
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: BIIB033 (Drug)
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: Avonex (Drug)
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: BIIB033 (Drug)
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: Avonex (Drug)
Placebo
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: Placebo (Other)
Placebo
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
干预措施: Avonex (Drug)
结局指标
主要结局
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
时间窗: 72 weeks
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
次要结局
- Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint(72 weeks)
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs(Up to 84 weeks)
- Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84(Up to 84 weeks)