Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (NEOS)

type of intervention

3-arm, Double-blind, Non-inferiority Study followed by an Open-label Extension, Randomized

recruitment status



International, VIC

type of ms

Relapsing MS, Relapsing remitting MS

Brief Summary

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

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

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

Anticipated Start Date

Already started

Recruitment Contacts

Novartis Pharmaceuticals

Phone Number:

Email: novartis.email@novartis.com

Further details

ClinicalTrials.gov ID NCT04926818





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