Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®
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).
Interventions
DRUGOzanimod
Specified dose on specified days
DRUGFingolimod
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized relapse rate (ARR) | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who did not have a confirmed relapse | At 12 and 24 months |
| Number of gadolinium enhancing (GdE) T1 lesions | At month 6 and month 12 |
| Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences | 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 | 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 |
| Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period | Up to 87 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 |
Countries
Australia, Italy, Mexico, Poland, Portugal, Puerto Rico, Romania, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed