drugset / Trial / NCT03958877

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

NCT03958877

Phase 3 Active not recruiting 152 enrolled Biogen
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-10-18
Primary completion
2027-05-20
Completion
2027-05-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Interferon beta-1a Protein / enzyme biologic 30 ug Intramuscular
Subject peginterferon beta-1a Protein / enzyme biologic 125 ug Subcutaneous