Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3- Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000516-22-PT

Enrollment

340

Registered

2018-11-27

Start date

2019-07-08

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: DIMETHYL FUMARATE CAS Number: 624-49-7 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria: Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS • Must have an EDSS score between 0.0 and 5.0. • Must have a body weight of =30 kg • Must have experienced =1 relapse in the 12 months prior to randomization (Day 1) or =2 relapses in the 24 months prior to randomization (Day 1). Note: Other protocol inclusion criteria may apply. Are the trial subjects under 18? yes Number of subjects for this age range: 340 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Key Exclusion Criteria: Participants having primary progressive, secondary progressive, or progressive RMS. • Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders. • History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study • Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization Note: other protocol defined Exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy of BG00012 and BIIB017, both compared with placebo, in pediatric subjects with RRMS.;Secondary Objective: Secondary objectives: to evaluate the safety and tolerability of BG00012 and BIIB017 and to assess the effect of BG00012 and BIIB017, both compared with placebo, on additional clinical and radiological measures of disease activity.;Primary end point(s): -The primary endpoint that relates to primary objective is the TTFR.;Timepoint(s) of evaluation of this end point: week 96	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy of BG00012 and BIIB017, both compared with placebo, in pediatric subjects with RRMS.;Secondary Objective: Secondary objectives: to evaluate the safety and tolerability of BG00012 and BIIB017 and to assess the effect of BG00012 and BIIB017, both compared with placebo, on additional clinical and radiological measures of disease activity.;Primary end point(s): -The primary endpoint that relates to primary objective is the TTFR.;Timepoint(s) of evaluation of this end point: week 96

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Secondary

Measure	Time frame
Secondary end point(s): -Occurrence of adverse events (AEs) and serious adverse events (SAEs) - Number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Weeks 48 and 96 - Number of Gd-enhancing lesions at Baseline and at Weeks 48 and 96 - Annualized relapse rate at Weeks 48 and 96;Timepoint(s) of evaluation of this end point: - total new lesions weeks 48 and 96 - relapse rate and proportion subjects experiencing 1 or more relapse (week 48 and 96) -degree of disability progression up to week 24	—

Measure

Time frame

Secondary end point(s): -Occurrence of adverse events (AEs) and serious adverse events (SAEs) - Number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Weeks 48 and 96 - Number of Gd-enhancing lesions at Baseline and at Weeks 48 and 96 - Annualized relapse rate at Weeks 48 and 96;Timepoint(s) of evaluation of this end point: - total new lesions weeks 48 and 96 - relapse rate and proportion subjects experiencing 1 or more relapse (week 48 and 96) -degree of disability progression up to week 24

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Countries

Bulgaria, Colombia, Croatia, Estonia, Greece, Hungary, Israel, Italy, Jordan, Korea, Republic of, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, United States

Contacts

Public Contact800MS301 Clinical Trial Team

Biogen Idec Research Limited

clinicaltrials@biogen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026