Running, not recruitingPhase 3Relapsing MSNCT039588772023-505624-56-002018-003008-38

What it found

Still running

No result yet.

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Part 1: Annualized Relapse Rate (ARR) at Week 48

    Week 48

    Relapses
  • Part 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

    Safety
  • Part 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

    Relapses
  • Part 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 lesions
  • Part 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 lesions
  • Part 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 lesions
  • Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96

    Weeks 24, 48, and 96

    MRI lesions
  • Part 1: Time to First Relapse

    Up to Week 96

    Relapses
  • Part 1: Percentage of Participants Free of Relapse at Weeks 48 and 96

    Weeks 48 and 96

    Relapses
  • Part 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 memory
  • Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96

    Baseline, Weeks 48, and 96

    Disability progression
  • Part 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…

    Related trials

    History

      1. Started

        Oct 2019

      2. Main results due

        May 2027

      3. Finished

        May 2027

      Assembled by software from public sources and not checked by people. Each record links to its source. Report an error