Clinical Trial

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Active, Not Recruiting Phase 3
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Summary
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.
Protocol Amendment History 32 amendments
This ClinicalTrials.gov record has been amended 32 times since 2019-05-20; most recent amendment 2025-09-10.
Status change: Recruiting → Active, Not Recruiting 2024-08-21
Trial Details
NCT Number NCT03958877
Lead Sponsor Biogen
Conditions Multiple Sclerosis, Relapsing-Remitting
Enrollment 152 participants
Start Date 2019-10-18
Primary Completion 2027-05-20 (estimated)
Study Completion 2027-05-20 (estimated)
Updated on ClinicalTrials.gov 2025-09-11