BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis (INSPIRE)

Biogen

Status and phase: Terminated; Phase 3

Conditions: Multiple Sclerosis, Secondary Progressive

Treatments: Drug: dimethyl fumarate; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02430532

2014-003021-18 (EudraCT Number)

109MS308

Details and patient eligibility

About

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

Enrollment: 58 patients

Sex: All

Ages: 18 to 58 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses.
• Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.
• Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.
• Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.

Key Exclusion Criteria:

• Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS as defined by the revised McDonald criteria.
• Had a recent clinical relapse (within 3 months) prior to randomization.
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

58 participants in 2 patient groups

Dimethyl fumarate

Experimental group

Description:

BG00012 120 mg (1 BG00012 120 mg capsule + 1 matching placebo capsule) orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID thereafter.

Treatment:

Drug: dimethyl fumarate

Other: Placebo

Placebo

Experimental group

Description:

BG00012 120 mg capsule orally once a day supplemented with matching placebo capsules for the first 4 weeks of treatment, as an additional blinding measure. Matched placebo capsules only thereafter.

Treatment:

Drug: dimethyl fumarate

Other: Placebo