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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06408259




Registration number
NCT06408259
Ethics application status
Date submitted
25/04/2024
Date registered
10/05/2024
Date last updated
4/07/2025

Titles & IDs
Public title
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
2022-501332-42
Secondary ID [2] 0 0
IM047-050
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Treatment: Drugs - Fingolimod
Other interventions - Placebo

Experimental: Ozanimod -

Active comparator: Fingolimod -


Treatment: Drugs: Ozanimod
Specified dose on specified days

Treatment: Drugs: Fingolimod
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized relapse rate (ARR)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Proportion of participants who did not have a confirmed relapse
Timepoint [1] 0 0
At 12 and 24 months
Secondary outcome [2] 0 0
Number of gadolinium enhancing (GdE) T1 lesions
Timepoint [2] 0 0
At month 6 and month 12
Secondary outcome [3] 0 0
Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences
Timepoint [3] 0 0
At 6, 12, 18, and 24 months
Secondary outcome [4] 0 0
Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period
Timepoint [4] 0 0
Up to 87 months
Secondary outcome [5] 0 0
Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period
Timepoint [5] 0 0
Up to 87 months
Secondary outcome [6] 0 0
Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period
Timepoint [6] 0 0
Up to 87 months
Secondary outcome [7] 0 0
Steady state plasma concentrations of ozanimod
Timepoint [7] 0 0
At day 90
Secondary outcome [8] 0 0
Steady state plasma concentrations of the primary active metabolite CC112273
Timepoint [8] 0 0
At day 90
Secondary outcome [9] 0 0
Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count
Timepoint [9] 0 0
At day 90 and throughout the study up to 24 months

Eligibility
Key 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.
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/07/2036
Actual
Sample size
Target
194
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 0113 - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Italy
State/province [11] 0 0
Campania
Country [12] 0 0
Italy
State/province [12] 0 0
Lombardia
Country [13] 0 0
Italy
State/province [13] 0 0
Roma
Country [14] 0 0
Mexico
State/province [14] 0 0
DIF
Country [15] 0 0
Poland
State/province [15] 0 0
Wielkopolskie
Country [16] 0 0
Portugal
State/province [16] 0 0
Braga
Country [17] 0 0
Portugal
State/province [17] 0 0
Coimbra
Country [18] 0 0
Portugal
State/province [18] 0 0
Lisboa
Country [19] 0 0
Portugal
State/province [19] 0 0
Porto
Country [20] 0 0
Romania
State/province [20] 0 0
Bucure?ti
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona [Barcelona]
Country [22] 0 0
Spain
State/province [22] 0 0
Pontevedra [Pontevedra]
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
Spain
State/province [24] 0 0
València
Country [25] 0 0
Spain
State/province [25] 0 0
Zaragoza
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
Turkey
State/province [27] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06408259