Active — Not RecruitingPhase 3

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

United States129 participantsStarted 2021-10-05

Plain-language summary

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

Age range10 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Annualized relapse rate (ARR) in target pediatric participants

Timeframe: Baseline up to 24 months

NCT IDNCT04926818

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-25