Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 1,841
- Locations
- 1
- Primary Endpoint
- Adjusted Annualized Relapse Rate (ARR)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
Daclizumab High Yield Process 150 mg SC
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
Intervention: BIIB019 (Daclizumab High Yield Process) (Biological)
Daclizumab High Yield Process 150 mg SC
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
Intervention: Interferon beta-1a Placebo (Drug)
IFN β-1a 30 µg IM
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
Intervention: Interferon beta-1a (Biological)
IFN β-1a 30 µg IM
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
Intervention: Daclizumab High Yield Process Placebo (Drug)
Outcomes
Primary Outcomes
Adjusted Annualized Relapse Rate (ARR)
Time Frame: Up to 144 weeks
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years). Data after participants switched to alternative MS medications are excluded.
Secondary Outcomes
- Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96(up to 96 weeks)
- Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks(Baseline and 96 weeks)
- Proportion of Participants With Sustained Disability Progression at 144 Weeks(Baseline through 144 weeks)
- Proportion of Participants Relapse-free at Week 144(144 weeks)