BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis (EXPLORE)

Biogen

Status and phase: Completed; Phase 2

Conditions: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Treatments: Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01156311

109MS201

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).

Enrollment: 108 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time.
• Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive.
• Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.

Key Exclusion Criteria:

• Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005).
• Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
• Pregnant or nursing women.
• Participation within 6 months prior to study enrollment in any other drug, biologic, or device study.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Glatiramer acetate (GA) and dimethyl fumarate

Experimental group

Description:

Participants taking a stable dose of GA for at least 12 months prior to the study remain on that dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).

Treatment:

Drug: dimethyl fumarate

Interferon beta (IFNβ) and dimethyl fumarate

Experimental group

Description:

Participants taking a stable dose of one of the IFNβ products for at least 12 months prior to the study remain on that product and dose throughout the study. Dimethyl fumarate is administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).

Treatment:

Drug: dimethyl fumarate