Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis (SELECTION)

Biogen

Status and phase: Completed; Phase 2

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Biological: BIIB019 (Daclizumab High Yield Process); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870740

205-MS-202

EUDRA CT No.: 2008-005559-46

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 517 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.

Key Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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517 participants in 6 patient groups

Group 1: DAC HYP 150 mg

Experimental group

Description:

Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.

Treatment:

Biological: BIIB019 (Daclizumab High Yield Process)

Group 1: DAC HYP 300 mg

Experimental group

Description:

Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.

Treatment:

Biological: BIIB019 (Daclizumab High Yield Process)

Group 2: Washout then DAC HYP 150 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Biological: BIIB019 (Daclizumab High Yield Process)

Group 2: DAC HYP 150 mg

Experimental group

Description:

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.

Treatment:

Biological: BIIB019 (Daclizumab High Yield Process)

Group 3: Washout then DAC HYP 300 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Biological: BIIB019 (Daclizumab High Yield Process)

Group 3: DAC HYP 300 mg

Experimental group

Description:

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.

Treatment:

Biological: BIIB019 (Daclizumab High Yield Process)