A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS

Neurology. 2011 Oct 18;77(16):1551-60. doi: 10.1212/WNL.0b013e318233b240. Epub 2011 Oct 5.


Objective: To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)).

Methods: This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life.

Results: There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified.

Conclusion: In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo.

Classification of evidence: This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+).

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Disability Evaluation
  • Disease Progression
  • Double-Blind Method
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Longitudinal Studies
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / pathology
  • Multiple Sclerosis / psychology
  • Myelin Basic Protein / therapeutic use*
  • Peptide Fragments / therapeutic use*
  • Quality of Life
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome


  • Myelin Basic Protein
  • Peptide Fragments
  • MBP-8298