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NCT Number: NCT06408259

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Children's Hospital, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
  • Meets at least 1 of the following criteria for disease activity:

i) At least 1 MS relapse/attack in the previous year prior to screening.

ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.

iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).

  • Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.

Exclusion criteria

  • Diagnosis of progressive forms of MS.
  • Active or chronic disease of the immune system other than MS.
  • Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Ozanimod

Drug

Specified dose on specified days

Fingolimod

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Annualized relapse rate (ARR)

    Time frame: Up to 2 years

Secondary outcomes

  1. Proportion of participants who did not have a confirmed relapse

    Time frame: At 12 and 24 months

  2. Number of gadolinium enhancing (GdE) T1 lesions

    Time frame: At month 6 and month 12

  3. Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences

    Time frame: At 6, 12, 18, and 24 months

  4. Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period

    Time frame: Up to 87 months

  5. Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period

    Time frame: Up to 87 months

  6. Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period

    Time frame: Up to 87 months

  7. Steady state plasma concentrations of ozanimod

    Time frame: At day 90

  8. Steady state plasma concentrations of the primary active metabolite CC112273

    Time frame: At day 90

  9. Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count

    Time frame: At day 90 and throughout the study up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Important dates

Study start
2025
Primary completion
2031
Study completion
2036
First posted
May 10, 2024
Registry last updated
Apr 28, 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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