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NCT Number: NCT04926818

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

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

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, CABA, Argentina

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About this study

The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 120 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
  • Diagnosis of multiple sclerosis
  • EDSS score of 0 to 5.5, inclusive
  • 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

  • Participants with progressive MS
  • Participants with an active, chronic disease of the immune system other than MS
  • Participants meeting the definition of ADEM
  • Participants with severe cardiac disease or significant findings on the screening ECG.
  • Participants with severe renal insufficiency

Treatment and study plan

Fingolimod

Drug

Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).

Other names: FTY720

ofatumumab

Drug

Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight).

Other names: OMB157

Siponimod

Drug

Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight).

Other names: BAF312

Fingolimod Placebo

Other

Fingolimod matching placebo capsule

Siponimod placebo

Other

Siponimod matching placebo tablet

Ofatumumab placebo

Other

Ofatumumab matching placebo autoinjector

Primary outcomes

  1. Annualized relapse rate (ARR) in target pediatric participants

    Time frame: Baseline up to 24 months

    Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).

Secondary outcomes

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

    Time frame: Baseline up to 24 months

    Frequency of relapses assessed by the annualized relapse rate (ARR) to historical interferon β-1a data. The ARR is defined as the average number of confirmed relapses per year. The historical data for interferon β-1a will derived from prior phase 3 studies.

  2. Annualized T2 lesion rate

    Time frame: Baseline up to 24 months

    Number of new/newly enlarged T2 lesions per year

  3. Neurofilament light chain (NfL) concentrations

    Time frame: Day 1, Months 3,6,12,18,24

    Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod

  4. Plasma Concentrations of ofatumumab

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

    Ofatumumab plasma concentrations

  5. Plasma Concentrations of siponimod

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

    Siponimod plasma concentrations

  6. Plasma Concentrations of siponimod metabolite (M17)

    Time frame: Pre-dose Month 3, 5 and Month 12

    Siponimod metabolite (M17) plasma concentration

  7. Percentage of participants with anti-ofatumumab antibodies

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

    Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab

  8. Number of adverse events and serious adverse events

    Time frame: Baseline up approximately 66 months

    Any clinically relevant finding that meets the criteria of an adverse event (as determined by the investigator) identified during the safety assessments (ECG, laboratory and ophthalmological data, pulmonary function tests and vital signs) will be reported as an adverse event

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: NEOS

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Jun 15, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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