NCT01051349

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.

Detailed description

This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BIIB019 (Daclizumab)	Administered as specified in the treatment arm.
BIOLOGICAL	trivalent seasonal influenza vaccine	All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site

Timeline

• Start date: 2010-03-31
• Primary completion: 2016-08-25
• Completion: 2016-08-25
• First posted: 2010-01-18
• Last updated: 2018-11-09
• Results posted: 2018-11-09

Locations

65 sites across 8 countries: Czechia, Germany, Hungary, India, Poland, Russia, Ukraine, United Kingdom