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Recruiting Phase 3 NCT06408259

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

Phase 3 – large-scale trial before approval
Conditions: Multiple Sclerosis, Relapsing-Remitting

Sponsor: Celgene

trial.available_in: БГ
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).
Who can participate
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.
Locations 10
Australia (1)
Royal Children's Hospital
Melbourne , Victoria
Eppie Yiu, Site 0113
Italy (1)
University of Naples Federico II
Naples , Campania
Vincenzo Brescia Morra, Site 0083
Mexico (1)
Local Institution - 0078
Mexico City , DIF
WITHDRAWN
Poland (1)
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan , Greater Poland Voivodeship
Barbara Steinborn, Site 0108
Puerto Rico (1)
Local Institution - 0134
Caguas
NOT_YET_RECRUITING
Romania (1)
Spitalul Clinic de Copii Doctor Victor Gomoiu
Bucharest , Bucharest
Raluca Teleanu, Site 0088
Spain (1)
Local Institution - 0096
Esplugues de Llobregat , Barcelona [Barcelona]
NOT_YET_RECRUITING
Taiwan (1)
National Taiwan University Hospital
Taipei
Wang-Tso Lee, Site 0115
Turkey (1)
Ondokuz Mayıs Universitesi
Samsun
murat terzi, Site 0109
United States (1)
Local Institution - 0114
Loma Linda , California
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
10 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
08.04.2025
Completion date
13.07.2036
Registry ID
NCT06408259
Source
anzctr
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