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

Last updated: January 8, 2026
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

3

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

Fingolimod

Ozanimod

Placebo

Clinical Study ID

NCT06408259
IM047-050
2022-501332-42
U1111-1281-5433
  • Ages 10-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of theMcDonald 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

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 systematicdisease.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 194
Treatment Group(s): 3
Primary Treatment: Fingolimod
Phase: 3
Study Start date:
April 08, 2025
Estimated Completion Date:
July 13, 2036

Connect with a study center

  • Local Institution - 0113

    Melbourne, Victoria 3052
    Australia

    Site Not Available

  • Local Institution - 0113

    Melbourne 2158177, Victoria 2145234 3052
    Australia

    Site Not Available

  • Royal Children's Hospital

    Melbourne 2158177, Victoria 2145234 3052
    Australia

    Active - Recruiting

  • Local Institution - 0083

    Napoli, Campania 80131
    Italy

    Site Not Available

  • University of Naples Federico II

    Napoli, Campania 80131
    Italy

    Site Not Available

  • University of Naples Federico II

    Napoli 9031661, Campania 3181042 80131
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Local Institution - 0081

    Milan 3173435, Lombardy 3174618 20133
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan 3173435, Lombardy 3174618 20132
    Italy

    Active - Recruiting

  • Local Institution - 0086

    Rome, Roma 00178
    Italy

    Site Not Available

  • Neurological Center Of Latium

    Rome, Roma 00178
    Italy

    Site Not Available

  • Neurological Center Of Latium

    Rome 3169070, Roma 00178
    Italy

    Active - Recruiting

  • Local Institution - 0078

    Mexico City, DIF 04530
    Mexico

    Site Not Available

  • Local Institution - 0078

    Mexico City 3530597, DIF 04530
    Mexico

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-355
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznań, Wielkopolskie 60-355
    Poland

    Site Not Available

  • 2Ca Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • 2Ca Braga

    Braga 2742032, 4710-243
    Portugal

    Active - Recruiting

  • Centro Hospitalar E Universitário De Coimbra

    Coimbra, 3000-602
    Portugal

    Site Not Available

  • Local Institution - 0105

    Coimbra, 3000-602
    Portugal

    Site Not Available

  • Centro Hospitalar E Universitário De Coimbra

    Coimbra 2740637, 3000-602
    Portugal

    Active - Recruiting

  • Unidade Local de Saúde de Coimbra, E.P.E.

    Coimbra 2740637, 3000-602
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Central

    Lisboa, 1169-050
    Portugal

    Site Not Available

  • Local Institution - 0104

    Lisboa, 1169-050
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Central

    Lisbon 2267057, 1169-050
    Portugal

    Active - Recruiting

  • Local Institution - 0102

    Porto, 4200-319
    Portugal

    Site Not Available

  • Local Institution - 0102

    Porto 2735943, 4200-319
    Portugal

    Site Not Available

  • Local Institution - 0134

    Caguas 4563008, 00725
    Puerto Rico

    Site Not Available

  • Local Institution - 0088

    Bucharest, București 022102
    Romania

    Site Not Available

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    Bucharest, București 041914
    Romania

    Active - Recruiting

  • Spitalul Clinic de Copii Doctor Victor Gomoiu

    Bucharest, București 022102
    Romania

    Site Not Available

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    Bucharest 683506, București 683504 041914
    Romania

    Active - Recruiting

  • Spitalul Clinic de Copii Doctor Victor Gomoiu

    Bucharest 683506, București 683504 022102
    Romania

    Active - Recruiting

  • Local Institution - 0096

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • Local Institution - 0096

    Esplugues de Llobregat 3122826, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra [Pontevedra] 36203
    Spain

    Site Not Available

  • Local Institution - 0098

    Vigo, Pontevedra [Pontevedra] 36203
    Spain

    Site Not Available

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo 3105976, Pontevedra [Pontevedra] 36203
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0094

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0101

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza 3104324, 50009
    Spain

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Active - Recruiting

  • Local Institution - 0109

    Samsun, 55270
    Turkey

    Site Not Available

  • Local Institution - 0109

    Samsun 740264, 55270
    Turkey (Türkiye)

    Site Not Available

  • Ondokuz Mayıs Universitesi

    Samsun 740264, 55270
    Turkey (Türkiye)

    Active - Recruiting

  • Local Institution - 0110

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Local Institution - 0110

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Local Institution - 0114

    Loma Linda, California 92354
    United States

    Site Not Available

  • Local Institution - 0130

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Local Institution - 0114

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Local Institution - 0130

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Axiom Clinical Research of Florida

    Tampa, Florida 33609
    United States

    Site Not Available

  • Local Institution - 0053

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Axiom Clinical Research of Florida

    Tampa 4174757, Florida 4155751 33609
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Local Institution - 0055

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Local Institution - 0093

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Local Institution - 0055

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Local Institution - 0093

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Local Institution - 0047

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Local Institution - 0047

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Local Institution - 0131

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Local Institution - 0132

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Local Institution - 0131

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • Local Institution - 0132

    Teaneck 5105262, New Jersey 5101760 07666
    United States

    Site Not Available

  • Local Institution - 0091

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Local Institution - 0091

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Local Institution - 0092

    Portland, Oregon 97225
    United States

    Site Not Available

  • Local Institution - 0092

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Local Institution - 0133

    El Paso 5520993, Texas 4736286 79912
    United States

    Site Not Available

  • Local Institution - 0033

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Local Institution - 0033

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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