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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
194
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Annualized relapse rate (ARR)
Time frame: Up to 2 years
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
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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CONTACT
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