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) - SELECTION

• Register: EUCTR
• Last refreshed on: 10 December 2012
• Main ID: EUCTR2008-005559-46-HU
• Date of registration: 05/06/2009
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Ltd.
• Public title: 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) - SELECTION
• Scientific title: 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) - SELECTION
• Date of first enrolment: 04/08/2009
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005559-46
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Multicenter If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Ukraine, United Kingdom

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Biogen Idec

• Name: Clinical Trial Information Desk
• Affiliation: Biogen Idec

Key inclusion & exclusion criteria

Inclusion criteria:
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Must be a subject from Study 205MS201 for at least 52 weeks and must have been compliant with the 205MS201 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization:
1. Subjects with any significant change in their medical status from Study 205MS201 that would preclude administration of DAC HYP including laboratory results or a current clinically significiant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS201. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment with DAC HYP.
2. 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.
3. Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant IFN-beta.
4. Current enrollment in any investigational drug study other than 205MS201.
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.
6. Other unspecified reasons that, in the opinion of the Investigator or the Biogen Idec Medical Director, make the subject unsuitable for enrollment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing-remitting Multiple Sclerosis/1
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab with Greek suufix
CAS Number: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab with Greek suufix
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Secondary Objective: Secondary objective of this study is:
• to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

Timepoint(s) of evaluation of this end point: Adverse events- as events occur
Lab evaluations and vital signs- at baseline and then monthly Physical examinations- at baseline, and then at wk 8, 20, 32, 44, 52, 60,
72 and at early termination visit if applicable Immunogenicity- at baseline, and then at wk 4, 8, 12, 16, 20, 32, 40, 52, 72 and at early termination visit if applicable

Main Objective: To assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation will include the following major components:
• An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who have completed 52 weeks of active therapy with DAC HYP in Study 205MS201.
• An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
• An assessment of safety and immunogenicity during re-initiation 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 205MS201
Note: The 6-month washout period is defined by the 24-week period between the last scheduled administration of DAC HYP at the Week 48 visit in 205MS201 and the re-initiation of DAC HYP at the Week 20 visit in 205MS202.

Primary end point(s): The primary end points of the study are safety as defined by the incidence of adverse events, change in laboratory evaluations, vital signs, physical examinations and immunogenicity as defined by the development of antibodies to DAC HYP.

Secondary Outcome(s)

Secondary end point(s): The secondary endpoint is to assess the durability of the effect of DAC
HYP on MS disease activity as measured by brain magnetic resonance
imaging (MRI) scans and clinical MS relapses.

Timepoint(s) of evaluation of this end point: MRI-at baseline and then at wk 20, 52 and at early termination visit if
applicable
Clinical relapse- as events occur

Secondary ID(s)

205MS202

2008-005559-46-CZ

Source(s) of Monetary Support

Biogen Idec Ltd