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

Phase 1

• 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; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000516-22-HU
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-02
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 340

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The primary objective of the study is to evaluate the efficacy of BG00012 and BIIB017, both<br> compared with placebo, in pediatric subjects with RRMS.<br> ;<br> Secondary Objective: Secondary objectives: to evaluate the safety and<br> tolerability of BG00012 and BIIB017 and to assess the<br> effect of BG00012 and BIIB017, both compared with<br> placebo, on additional clinical and radiological measures<br> of disease activity.<br> ;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

Secondary Outcome Measures

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