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Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
Summary
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Official title: 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
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2021-10-05
Completion Date
2031-03-06
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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
Locations (51)
Arkansas Childrens Hosp Rsch Inst
Little Rock, Arkansas, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Esneux, Belgium
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Curitiba, Paraná, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Lo Barnechea, Santiago Metropolitan, Chile
Novartis Investigative Site
Zagreb, Croatia
Novartis Investigative Site
Tallinn, Estonia
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Strasbourg, France
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Novartis Investigative Site
Göttingen, Lower Saxony, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Guatemala City, Guatemala
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Lucknow, Uttar Pradesh, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Petah Tikva, Israel
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Riga, Latvia
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Gdansk, Poland
Novartis Investigative Site
Lodz, Poland
Novartis Investigative Site
Poznan, Poland
Novartis Investigative Site
Warsaw, Poland
Novartis Investigative Site
Coimbra, Portugal
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Belgrade, Serbia
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Barakaldo, Vizcaya, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Tainan, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Samsun, Atakum, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Karsiyaka, Turkey (Türkiye)
Novartis Investigative Site
Kocaeli, Turkey (Türkiye)