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

Condition(s) studied

Investigational drug(s) / intervention(s)

Fingolimod: Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).

Ofatumumab: Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight).

Siponimod: Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight).

Fingolimod placebo: Fingolimod matching placebo capsule

Siponimod placebo: Siponimod matching placebo tablet

Ofatumumab placebo: Ofatumumab matching placebo autoinjector

Study summary

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

Eligibility

Primary outcome measure(s)

• Annualized relapse rate (ARR) in target pediatric participants — Baseline up to 24 months
  Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).

Trial sites (51)

+ 11 more sites — see the full list on the official registry below.

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