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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

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
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Italy
State/province [9] 0 0
Campania
Country [10] 0 0
Italy
State/province [10] 0 0
Lombardia
Country [11] 0 0
Italy
State/province [11] 0 0
Roma
Country [12] 0 0
Mexico
State/province [12] 0 0
DIF
Country [13] 0 0
Poland
State/province [13] 0 0
Wielkopolskie
Country [14] 0 0
Portugal
State/province [14] 0 0
Braga
Country [15] 0 0
Portugal
State/province [15] 0 0
Coimbra
Country [16] 0 0
Portugal
State/province [16] 0 0
Lisboa
Country [17] 0 0
Portugal
State/province [17] 0 0
Porto
Country [18] 0 0
Romania
State/province [18] 0 0
Bucure?ti
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona [Barcelona]
Country [20] 0 0
Spain
State/province [20] 0 0
Pontevedra [Pontevedra]
Country [21] 0 0
Spain
State/province [21] 0 0
Sevilla
Country [22] 0 0
Spain
State/province [22] 0 0
València
Country [23] 0 0
Spain
State/province [23] 0 0
Zaragoza
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei
Country [25] 0 0
Turkey
State/province [25] 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


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