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

  • End date
    Nov 5, 2029
  • participants needed
  • sponsor
Updated on 25 July 2022
relapsing multiple sclerosis
magnetic resonance imaging brain


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.

Condition Multiple Sclerosis, Relapsing-Remitting
Treatment BIIB017 (peginterferon beta-1a), Interferon beta type 1a
Clinical Study IdentifierNCT03958877
Last Modified on25 July 2022


Yes No Not Sure

Inclusion Criteria

Part 1
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 5.5
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) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1)
Part 2
• Participants who completed the study treatment in Part 1 (Week 96 Visit), as per

Exclusion Criteria

Part 1
Primary progressive, secondary progressive, or progressive relapsing. These conditions
require the presence of continuous clinical disease worsening over a period of at
History of severe allergic or anaphylactic reactions or known drug hypersensitivity
least 3 months. Participants with these conditions may also have superimposed relapses
Known allergy to any component of Avonex or BIIB017 formulation
but are distinguished from relapsing participants by the lack of clinically stable
periods or clinical improvement
Part 2
The participant could not tolerate BIIB017 in Part 1
Occurrence of an MS relapse that has occurred within 30 days prior to randomization
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
(Day 1) and/or the participant has not stabilized from a previous relapse prior to
randomization (Day 1)
Any previous treatment with PEGylated human IFN β-1a
Any significant changes in medical history occurring after enrollment in Part 1
including laboratory test abnormalities or current clinically significant conditions
that, in the opinion of the Investigator, would have excluded the participant's
participation in Part 1. The Investigator must re-assess the participant's medical
fitness for participation and consider any factors that would preclude treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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