Overview

This trial is active, not recruiting.

Conditions multiple sclerosis, relapsing-remitting, multiple sclerosis
Treatment dimethyl fumarate
Phase phase 3
Sponsor Biogen
Start date August 2015
End date June 2018
Trial size 218 participants
Trial identifier NCT02525874, 109MS310, 2015-001973-42

Summary

The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter
dimethyl fumarate BG00012
Initial oral dose for 7 days with maintenance dose thereafter

Primary Outcomes

Measure
Change in lymphocyte subset counts during the first year of treatment.
time frame: One year

Secondary Outcomes

Measure
Changes in ALCs during the first year of treatment.
time frame: One year
Changes in immunoglobulin G (IgG) isotypes during the first year of treatment.
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Key Inclusion Criteria: - Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. - Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011] Key Exclusion Criteria: - History of or positive test result at Screening for: - human immunodeficiency virus - hepatitis C virus antibody - hepatitis B infection - Drug or alcohol abuse within 1 year prior to Screening. - Prior treatment with any of the following: - cladribine - mitoxantrone - total lymphoid irradiation - alemtuzumab - T-cell or T-cell receptor vaccination - any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab - Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1): - DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure - cyclosporine - azathioprine - methotrexate - mycophenolate mofetil - intravenous (IV) Ig - plasmapheresis or cytapheresis NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Additional Information

Official title An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biogen.