Multiple Sclerosis, Relapsing-RemittingPhase 3NCT06408259
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
A Phase 3 study testing Ozanimod and Fingolimod in people with Multiple Sclerosis, Relapsing-Remitting, run by Bristol-Myers Squibb at 33 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Ozanimod and Fingolimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 33 sitesin 11 countries
- Study dates
- 8 Apr 2025to 13 Jul 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- At least 1 MS relapse/attack in the previous year prior to screening.
- At least 2 MS relapses/attacks in the previous 2 years prior to screening.
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
33 sites in 11 countries
United States12 sites, 9 recruiting
- Withdrawn
Local Institution - 0093
Chicago, Illinois, 60611
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Moon Hee Hur, Site 0055, 773-702-6673
- Withdrawn
Local Institution - 0091
Cincinnati, Ohio, 45229
- Not yet recruiting
Local Institution - 0133
El Paso, Texas, 79912
Site 0133
- Not yet recruiting
Local Institution - 0114
Loma Linda, California, 92354
Site 0114
- Recruiting
University of Louisville, Norton Children's Research Institute
Louisville, Kentucky, 40202
Michael Sweeney, Site 0047, 502-629-5606
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Ahmed Obeidat, Site 0033, 414-955-0619
- Not yet recruiting
Local Institution - 0131
New Brunswick, New Jersey, 08901
Site 0131
- Not yet recruiting
Local Institution - 0092
Portland, Oregon, 97225
Site 0092
- Recruiting
University of California Davis Health
Sacramento, California, 95817
Frederick Bassal, Site 0130, 916-734-3588
- Recruiting
University of South Florida
Tampa, Florida, 33612
Natalie Moreo, Site 0053, 813-396-9478
- Withdrawn
Local Institution - 0132
Teaneck, New Jersey, 07666
Spain5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0096
Esplugues de Llobregat, Barcelona [Barcelona], 08950
Site 0096
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
SARA EICHAU MADUEÑO, Site 0099, 0034955006627
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Francisco Pérez-Miralles, Site 0094
- Recruiting
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [Pontevedra], 36203
Elena Rodriguez, Site 0098, +34986217300
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Jesus Martin Martinez, Site 0101
Italy4 sites, 4 recruiting
- Recruiting
Ospedale San Raffaele
Milan, Lombardy, 20132
Massimo Filippi, Site 0082, +390226433958
- Not yet recruiting
Local Institution - 0081
Milan, Lombardy, 20133
Site 0081
- Recruiting
University of Naples Federico II
Naples, Campania, 80131
Vincenzo Brescia Morra, Site 0083, +39081743741
- Recruiting
Neurological Center Of Latium
Rome, Roma, 00178
Carlo Pozzilli, Site 0086, 06.3377.5441
Portugal4 sites, 3 recruiting
- Recruiting
2Ca Braga
Braga, 4710-243
Joao Cerqueira, Site 0103, +351915301556
- Recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, 3000-602
Filipe Palavra, Site 0105, +351914632128
- Recruiting
Centro Hospitalar de Lisboa Central
Lisbon, 1169-050
João Sequeira, Site 0104, 00351912576085
- Withdrawn
Local Institution - 0102
Porto, 4200-319
Romania2 sites, 2 recruiting
- Recruiting
Spitalul Clinic de Copii Doctor Victor Gomoiu
Bucharest, Bucharest, 022102
Raluca Teleanu, Site 0088, 0040722241042
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Cristina Pomeran, Site 0087, 0040723233463
Australia1 site, 1 recruiting
- Recruiting
Royal Children's Hospital
Melbourne, Victoria, 3052
Eppie Yiu, Site 0113, 6139455661
Poland1 site
- Completed
Local Institution - 0108
Poznan, Greater Poland Voivodeship, 60-355
Puerto Rico1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0134
Caguas, 00725
Site 0134
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Wang-Tso Lee, Site 0115, 0972651495
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayıs Universitesi
Samsun, 55270
murat terzi, Site 0109, +905323156884
About this study
Official title: A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
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).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Ozanimod, Fingolimod, Placebo
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Specified dose on specified days
FingolimodDrug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod | Experimental | Not described Receives: Drug: Ozanimod; Other: Placebo |
| Fingolimod | Active comparator | Not described Receives: Drug: Fingolimod; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized relapse rate (ARR)
Measured: Up to 2 years
Secondary outcomes (9)
Proportion of participants who did not have a confirmed relapse
Measured: At 12 and 24 months
Number of gadolinium enhancing (GdE) T1 lesions
Measured: At month 6 and month 12
Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences
Measured: 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
Measured: Up to 87 months
Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period
Measured: Up to 87 months
Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period
Measured: Up to 87 months
Steady state plasma concentrations of ozanimod
Measured: At day 90
Steady state plasma concentrations of the primary active metabolite CC112273
Measured: At day 90
Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count
Measured: At day 90 and throughout the study up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start8 Apr 2025
- Primary completion11 Apr 2031 (estimated)
- Study completion13 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408259
- Sponsor's protocol ID
- IM047-050
- Other IDs
- 2022-501332-42, U1111-1281-5433
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06408259
- Acronym / sponsor ID
- IM047-050
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 11 Apr 2031 (estimated)
- Study completion
- 13 Jul 2036 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozanimod | Experimental | Drug: Ozanimod, Other: Placebo |
| Fingolimod | Active comparator | Drug: Fingolimod, Other: Placebo |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
- At least 2 MS relapses/attacks in the previous 2 years prior to screening.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodSpecified dose on specified days | Drug | Ozanimod |
| FingolimodSpecified dose on specified days | Drug | Fingolimod |
| PlaceboSpecified dose on specified days | Other | Fingolimod, Ozanimod |
Primary outcome
Annualized relapse rate (ARR)
Time frame: Up to 2 years
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozanimod and Fingolimod in people with Multiple Sclerosis, Relapsing-Remitting, run by Bristol-Myers Squibb at 33 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Spain, Italy, Portugal, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized relapse rate (ARR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.