A Multicenter, Open-label, Extension Study to Evaluate the Long term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- The primary objective of this study is to assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS
研究概览
简要总结
All subjects will receive one DAC HYP 150 mg SC injection every 4 weeks. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
After the first 12 weeks in this study, subjects will have the option of administering DAC HYP at home. Subjects who are not able to administer their own dose or prefer not to administer their own dose of DAC HYP will be given the option to choose another individual to administer their treatment or to have their treatment administered by staff at the study site.
A protocol-defined futility analysis in the 205MS201 study did not find evidence of futility at the proposed dose of DAC HYP, which was originally selected based on the findings of the completed Phase 2 DAC-1012 study. Additionally, the ongoing safety review of the 205MS201 and 205MS202 studies supports continued dosing and initiation of home dosing for subjects who have previously tolerated DAC HYP dosing in the clinic. Prior to self-administration of DAC HYP as an SC injection in this study, subjects will have received DAC HYP for a minimum of 15 months and a maximum of 27 months comprising their treatment in the 205MS201 and 205MS202 studies plus the first 3 months of observed therapy in the current study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.
- •2.Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator.
- •3.Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
排除标准
- •1.Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject’s participation in the 205MS201 or 205MS202 studies.
- •The Investigator must re review the subject’s medical fitness for participation and must consider any diseases that would preclude treatment.
- •2.Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE.
- •3.Current enrollment in any investigational drug study other than Study 205MS
- •4.Ongoing treatment with any approved or experimental disease-modifying treatment for MS.
- •5.Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.
结局指标
主要结局
The primary objective of this study is to assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS
时间窗: 144 weeks
次要结局
- The secondary objectives of this study are to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population.(•Immunogenicity)