Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
About the study
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
- Diagnosis of multiple sclerosis
- EDSS score of 0 to 5.5, inclusive
- At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
EXCLUSION CRITERIA
Exclusion Criteria:
- Participants with progressive MS
- Participants with an active, chronic disease of the immune system other than MS
- Participants meeting the definition of ADEM
- Participants with severe cardiac disease or significant findings on the screening ECG.
- Participants with severe renal insufficiency
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Multiple Sclerosis (MS)
Age
10+
Phase
PHASE3
Participants Needed
120
Est. Completion Date
Dec 23, 2031
Treatment Type
INTERVENTIONAL
Sponsor
Novartis
ClinicalTrials.gov NCT Identifier
NCT04926818
Study Number
CBAF312D2301
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