A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 517
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
研究概览
简要总结
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:
- An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
- An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
- An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
- An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.
The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.
详细描述
This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.
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
- •Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
排除标准
- •Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
- •Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
- •Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Group 1: DAC HYP 150 mg
Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
Group 1: DAC HYP 300 mg
Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
Group 2: Washout then DAC HYP 150 mg
Participants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
Group 2: Washout then DAC HYP 150 mg
Participants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
干预措施: Placebo (Drug)
Group 2: DAC HYP 150 mg
Participants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
Group 3: Washout then DAC HYP 300 mg
Participants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
Group 3: Washout then DAC HYP 300 mg
Participants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
干预措施: Placebo (Drug)
Group 3: DAC HYP 300 mg
Participants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
干预措施: BIIB019 (Daclizumab High Yield Process) (Biological)
结局指标
主要结局
Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
时间窗: Up to 72 Weeks
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Number of Participants With Treatment-emergent Adverse Events (AEs)
时间窗: Up to 72 weeks
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
Number of Participants With Abnormalities in Vital Signs
时间窗: Up to Week 72
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
时间窗: Up to 72 Weeks
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
时间窗: Up to 72 weeks
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
次要结局
- Adjusted Annualized Relapse Rate(Up to 72 weeks)
- Estimated Proportion of Participants With a Relapse(Up to 72 weeks)
- Mean Number of New Gadolinium-enhancing Lesions(Week 20, Week 52)
- Mean Number of New or Newly-enlarging T2 Hyperintense Lesions(Baseline, Week 20, Week 52)
- Mean Volume of New T1 Hypointense Lesions(Baseline, Week 20, Week 52)
- Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions(Baseline, Week 52)
- Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions(Baseline, Week 52)
- Rate of Percentage Change From Baseline in Mean Total Brain Volume(Baseline, Week 52)