Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

Biogen

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02525874

2015-001973-42 (EudraCT Number)

109MS310

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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218 participants in 1 patient group

dimethyl fumarate

Experimental group

Description:

120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter

Treatment:

Drug: dimethyl fumarate