105MS306
What it found
No result yet.
What was tested
Treatment tested
- Peginterferon beta-1a
Interferon alpha/beta receptor agonist
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
Part 1: Annualized Relapse Rate (ARR) at Week 48
Week 48
RelapsesPart 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation
From Week 96 to Week 196
SafetyPart 1- The primary endpoint is the annualized relapse rate (ARR) at Week 96.
Relapses
Other measures (50)
Part 1: ARR at Week 96
Week 96
RelapsesPart 1: Percentage of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 24, 48, and 96
Weeks 24, 48, and 96
MRI lesionsPart 1: Percentage of Participants Free of New MRI Activity in the Brain (Free of Gadolinium [Gd]-Enhancing Lesions and New or Newly Enlarging T2 Hyperintense Lesions) at Weeks 24, 48, and 96
Weeks 24, 48, and 96
MRI lesionsPart 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96
Weeks 24, 48, and 96
MRI lesionsPart 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96
Weeks 24, 48, and 96
MRI lesionsPart 1: Time to First Relapse
Up to Week 96
RelapsesPart 1: Percentage of Participants Free of Relapse at Weeks 48 and 96
Weeks 48 and 96
RelapsesPart 1: Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT)
Baseline, Weeks 24, 48, 72, and 96
Thinking and memoryPart 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96
Baseline, Weeks 48, and 96
Disability progressionPart 1: Change from Baseline in the Quality of Life as Measured by the Pediatric Quality of Life Inventory (PedsQL) at Weeks 24, 48, 72 and 96
Baseline, Weeks 24, 48, 72 and 96
Quality of life (reported by participants)
Who could take part
Relapsing MS · 10 to 18
Key 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 protocol. Key Exclusion Criteria: Part 1: * Primary progressive, secondary progressive, or progressive relapsing MS. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement. * History of severe allergic or anaphylactic reactions or known drug hypersensitivity. * Known allergy to any component of Avonex or BIIB017 formulation. * Occurrence of an MS relapse that has occurred within 30 days prior to randomization (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. Part 2: * 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. * The participant could not tolerate BIIB017 in Part 1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Oct 2019
Main results due
May 2027
Finished
May 2027
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