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Recruiting NCT06408259

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

Phase III Interventional Multiple Sclerosis, Relapsing-Remitting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ozanimod, Fingolimod, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Relapsing-Remitting. Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Italy, Mexico, Poland +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

Interventions

  • Drug Ozanimod
    Specified dose on specified days
  • Drug Fingolimod
    Specified dose on specified days
  • Other Placebo
    Specified dose on specified days

Primary outcome measures

  • Annualized relapse rate (ARR) [Time frame: Up to 2 years]
Secondary outcome measures (9)
  • Proportion of participants who did not have a confirmed relapse [Time frame: At 12 and 24 months]
  • Number of gadolinium enhancing (GdE) T1 lesions [Time frame: At month 6 and month 12]
  • Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences [Time frame: At 6, 12, 18, and 24 months]
  • 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]
  • 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]
  • Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period [Time frame: Up to 87 months]
  • Steady state plasma concentrations of ozanimod [Time frame: At day 90]
  • Steady state plasma concentrations of the primary active metabolite CC112273 [Time frame: At day 90]
  • Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count [Time frame: At day 90 and throughout the study up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Local Institution - 0114 — Loma Linda
  • University of California Davis Health — Sacramento
  • University of South Florida — Tampa
  • Local Institution - 0093 — Chicago
  • University of Chicago Medical Center — Chicago
  • University of Louisville, Norton Children's Research Institute — Louisville
  • Local Institution - 0131 — New Brunswick
  • Local Institution - 0132 — Teaneck
  • … and 4 more centers
Spain · 5 centers
  • Local Institution - 0096 — Esplugues de Llobregat
  • CHUVI- Hospital Alvaro Cunqueiro — Vigo
  • Hospital Universitario Virgen Macarena — Seville
  • Hospital Universitari i Politecnic La Fe — Valencia
  • Hospital Universitario Miguel Servet — Zaragoza
Italy · 4 centers
  • University of Naples Federico II — Naples
  • Ospedale San Raffaele — Milan
  • Local Institution - 0081 — Milan
  • Neurological Center Of Latium — Rome
Portugal · 4 centers
  • 2Ca Braga — Braga
  • Unidade Local de Saúde de Coimbra, E.P.E. — Coimbra
  • Centro Hospitalar de Lisboa Central — Lisbon
  • Local Institution - 0102 — Porto
Romania · 2 centers
  • Spitalul Clinic de Copii Doctor Victor Gomoiu — Bucharest
  • Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest
Australia · 1 center
  • Royal Children's Hospital — Melbourne
Mexico · 1 center
  • Local Institution - 0078 — Mexico City
Poland · 1 center
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
Puerto Rico · 1 center
  • Local Institution - 0134 — Caguas
Taiwan · 1 center
  • National Taiwan University Hospital — Taipei
Turkey (Türkiye) · 1 center
  • Ondokuz Mayıs Universitesi — Samsun

Identifiers

NCT: NCT06408259 · IM047-050 · 2022-501332-42 · U1111-1281-5433

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗