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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Collaborator: AbbVie
• Treatments: Daclizumab; Immunoglobulin G; Interferon beta-1a; Interferon-beta; Interferons

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.