Phase 3
N=1,841
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01064401 ↗Enrolled (actual)
1,841
Serious AEs
22.5%
Results posted
Jul 2016
Primary outcome: Primary: Adjusted Annualized Relapse Rate (ARR) — 0.393; 0.216 relapses per person-years — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BIIB019 (Daclizumab High Yield Process) (Biological); Interferon beta-1a Placebo (Drug); Interferon beta-1a (Biological); Daclizumab High Yield Process Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Annualized Relapse Rate (ARR) |
0.393; 0.216 | < 0.0001 sig |
| SECONDARY Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96 |
9.44; 4.31 | < 0.0001 sig |
| SECONDARY Proportion of Participants With Sustained Disability Progression at 144 Weeks |
0.203; 0.162 | 0.1575 |
| SECONDARY Proportion of Participants Relapse-free at Week 144 |
0.508; 0.673 | < 0.0001 sig |
| SECONDARY 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 |
23; 19 | 0.0176 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01064401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.