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

Phase 3

Recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Fingolimod; Drug: Ozanimod; Other: Placebo

• Registration Number: NCT06408259
• Lead Sponsor: Celgene

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-10
• Study Start: 2025-04-08
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2031-04-11
• Study Completion: 2036-07-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fingolimod	Placebo	-
Fingolimod	Fingolimod	-
Ozanimod	Ozanimod	-
Ozanimod	Placebo	-

Primary Outcome Measures

Name	Time	Method
Annualized relapse rate (ARR)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who did not have a confirmed relapse	At 12 and 24 months
Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period	Up to 87 months
Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period	Up to 87 months
Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences	At 6, 12, 18, and 24 months
Steady state plasma concentrations of ozanimod	At day 90
Steady state plasma concentrations of the primary active metabolite CC112273	At day 90
Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count	At day 90 and throughout the study up to 24 months
Number of gadolinium enhancing (GdE) T1 lesions	At month 6 and month 12
Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period	Up to 87 months

Trial Locations

Locations (34)

Centro Hospitalar de Lisboa Central; 🇵🇹 Lisboa, Portugal

Local Institution - 0110; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0114; 🇺🇸 Loma Linda, California, United States

Local Institution - 0130; 🇺🇸 Sacramento, California, United States

UCSF Benioff Children's Hospital San Francisco; 🇺🇸 San Francisco, California, United States

Axiom Clinical Research of Florida; 🇺🇸 Tampa, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Local Institution - 0093; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0055; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0047; 🇺🇸 Louisville, Kentucky, United States

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