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: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-27
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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