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

An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	BIIB017 (peginterferon beta-1a)	Administered as specified in the treatment arm
DRUG	Interferon beta type 1a	Administered as specified in the treatment arm

Timeline

• Start date: 2019-10-18
• Primary completion: 2027-05-20
• Completion: 2027-05-20
• First posted: 2019-05-22
• Last updated: 2025-09-11

Locations

65 sites across 22 countries: United States, Argentina, Australia, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Kuwait, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Tunisia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study