NCT04926818

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

A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 120 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.

Conditions

• Multiple Sclerosis (MS)

Interventions

Type	Name	Description
DRUG	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).
DRUG	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).
DRUG	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).
OTHER	Fingolimod placebo	Fingolimod matching placebo capsule
OTHER	Siponimod placebo	Siponimod matching placebo tablet
OTHER	Ofatumumab placebo	Ofatumumab matching placebo autoinjector

Timeline

• Start date: 2021-10-05
• Primary completion: 2026-03-25
• Completion: 2031-03-06
• First posted: 2021-06-15
• Last updated: 2026-03-30

Locations

51 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Estonia, France, Germany, Guatemala, India, Israel, Italy, Latvia, Mexico, Poland, Portugal, Serbia, Slovakia, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study