Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Phase 3

Withdrawn

• Conditions: Relapsing-Remitting Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis
• Interventions: Drug: dimethyl fumarate; Drug: Placebo

• Registration Number: NCT02428218
• Lead Sponsor: Biogen

Brief Summary

The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and to compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-28
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13
• Study Start: 2016-05
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Informed consent and assent as appropriate
• Must have a body weight of ≥30 kg
• Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric multiple sclerosis (MS)
• Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive

Key

Exclusion Criteria

• Primary progressive, secondary progressive, or progressive relapsing MS.
• History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
• History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (DMF) or fumaric acid esters.
• Prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
• Prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV) immunoglobulin, plasmapheresis or cytapheresis.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BG00012	dimethyl fumarate	Participants will receive 120 mg capsule(s) BG00012 taken orally.
Placebo	Placebo	Participants will receive matching placebo capsule(s) taken orally.

Primary Outcome Measures

Name	Time	Method
Time to first multiple sclerosis (MS) relapse	Up to week 104	Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.

Secondary Outcome Measures

Name	Time	Method
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)	Up to week 104
Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans	Weeks 24, 48, 72 and 96
Number of gadolinium-enhancing Lesions	Baseline, and weeks 24, 48, 72 and 96
Annualized MS relapse rate	weeks 48 and 96