A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Overview
- Phase
- Phase 2
- Intervention
- BIIB033
- Conditions
- Multiple Sclerosis
- Sponsor
- Biogen
- Enrollment
- 419
- Locations
- 68
- Primary Endpoint
- Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.
Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
- •RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
- •All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment
Exclusion Criteria
- •A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
- •Previous history of clinically significant disease.
- •Plans to undergo elective major procedures/surgeries at any time during the study.
- •Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
- •RRMS subjects with any history of inadequate response to any approved interferon β preparation
- •History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
- •History or evidence of drug or alcohol abuse within 2 years prior to randomization
- •Note: Other protocol defined inclusion/exclusion criteria may apply.
Arms & Interventions
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: BIIB033
BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84.
Intervention: BIIB033
BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84.
Intervention: Avonex
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: Avonex
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: BIIB033
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: Avonex
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: BIIB033
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: Avonex
Placebo
Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: Placebo
Placebo
Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.
Intervention: Avonex
Outcomes
Primary Outcomes
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
Time Frame: 72 weeks
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Secondary Outcomes
- Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint(72 weeks)
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs(Up to 84 weeks)
- Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84(Up to 84 weeks)