Phase 2
Completed N=419
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Source: ClinicalTrials.gov NCT01864148 ↗Enrolled (actual)
419
Serious AEs
15.3%
Results posted
May 2017
Primary outcomePrimary: Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint — 0.516; 0.511; 0.656; 0.688 proportion of participants — p=0.9584
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint |
0.516; 0.511; 0.656; 0.688; 0.412 | 0.9584 |
| SECONDARY Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint |
0.403; 0.304; 0.509; 0.489; 0.369 | 0.3058 |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs |
79; 39; 84; 79; 73; 275 | — |
| SECONDARY Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84 |
0.00; 0.01; 7.79; 0.42; 66.70; 244.76 | — |
Eligibility Criteria
Key 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
Key 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.
Data sourced from ClinicalTrials.gov (NCT01864148). 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. Informational only — not medical advice.