Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis ((DECIDE))

Biogen

Status and phase: Completed; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Daclizumab High Yield Process Placebo; Biological: BIIB019 (Daclizumab High Yield Process); Biological: Interferon beta-1a; Drug: Interferon beta-1a Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064401

205MS301

2009-012500-11

Details and patient eligibility

About

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

Enrollment: 1,841 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
• Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
• Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment

Key Exclusion Criteria:

• Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
• History of treatment with Daclizumab High Yield Process (Dac HYP)
• History of malignancy
• History of severe allergic or anaphylactic reactions
• Known hypersensitivity to study drugs or their excipients
• History of abnormal laboratory results indicative of any significant disease
• History of human immunodeficiency virus (HIV) or other immunodeficient conditions
• History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
• History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
• History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
• An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
• Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
• Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
• Exposure to varicella zoster virus within 21 days before screening

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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1,841 participants in 2 patient groups

Daclizumab High Yield Process 150 mg SC

Experimental group

Description:

Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks

Treatment:

Biological: BIIB019 (Daclizumab High Yield Process)

Drug: Interferon beta-1a Placebo

IFN β-1a 30 µg IM

Active Comparator group

Description:

Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks

Treatment:

Biological: Interferon beta-1a

Drug: Daclizumab High Yield Process Placebo