MSFrontier

NEOS

A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension
Running, not recruitingPhase 3Relapsing MSNCT049268182024-511686-11-002020-002700-39

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ofatumumab

    B-lymphocyte antigen CD20 binding agent

  • Siponimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

Compared with

Placebo or sham

  • Fingolimod placebo
  • Siponimod placebo
  • Ofatumumab placebo
  • Placebo to Siponimod (BAF312) [Mayzent] film-coated tablets
  • Placebo to Ofatumumab (OMB157) [Kesimpta]
  • Placebo to Fingolimod (FTY720) [Gilenya] 0.25mg & 0.5mg

What it measured

Main measures

  • Annualized relapse rate (ARR) in target pediatric participants

    Baseline up to 24 months

    Relapses

  • Annualized relapse rate (ARR of confirmed relapses)

    Relapses

Other measures (12)

  • Annualized relapse rate (ARR) as compared to historical interferon β-1a data

    Baseline up to 24 months

    RelapsesImmune response

  • Annualized T2 lesion rate

    Baseline up to 24 months

    MRI lesions

  • Neurofilament light chain (NfL) concentrations

    Day 1, Months 3,6,12,18,24

    Blood or spinal fluid markers

  • Plasma Concentrations of ofatumumab

    Day 1, pre-dose for Day 7, Months 2,3,5,6,12,18,24

    How the body handles the medicine

  • Plasma Concentrations of siponimod

    Day 1 (2,3,4,6 h), Day 3 (2,3,4,6 h), pre-dose for Months 1 (pre, 3h), 3,5,12

    How the body handles the medicine

  • Plasma Concentrations of siponimod metabolite (M17)

    Pre-dose Month 3, 5 and Month 12

    How the body handles the medicine

  • Percentage of participants with anti-ofatumumab antibodies

    Day 1, Pre-Dose Months 2,3,5,6,12,18,24

    Immune response

  • Number of adverse events and serious adverse events

    Baseline up approximately 66 months

    Safety

  • -Annualized relapse rate (ARR of confirmed relapses)

    Relapses

  • Number of new or newly enlarging T2 lesions on MRI per year (annualized T2 lesion rate)

    MRI lesions

Who could take part

Relapsing MS · 10 to 17

Inclusion Criteria: 1. Between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization 2. Diagnosis of multiple sclerosis 3. EDSS score of 0 to 5.5, inclusive 4. At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months Exclusion Criteria: 1. Participants with progressive MS 2. Participants with an active, chronic disease of the immune system other than MS 3. Participants meeting the definition of ADEM 4. Participants with severe cardiac disease or significant findings on the screening ECG. 5. Participants with severe renal insufficiency

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Papers

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    Related trials

    History

      1. Started

        Oct 2021

      2. Main results due

        Mar 2026

      3. Finished

        Feb 2031

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