129
Participants
Start Date
October 5, 2021
Primary Completion Date
March 2, 2027
Study Completion Date
November 19, 2031
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
Novartis Investigative Site, Vienna
Novartis Investigative Site, Parkville
Novartis Investigative Site, Esneux
Novartis Investigative Site, Ghent
Novartis Investigative Site, Zagreb
Novartis Investigative Site, Taipei
Novartis Investigative Site, Belgrade
Novartis Investigative Site, Tallinn
Childrens National Medical Center, Washington D.C.
Axiom Clinical Research of Florida, Tampa
Novartis Investigative Site, Montpellier
Novartis Investigative Site, Istanbul
Novartis Investigative Site, Izmir
Novartis Investigative Site, Göttingen
Novartis Investigative Site, Seville
Novartis Investigative Site, Kocaeli
Novartis Investigative Site, Bochum
Novartis Investigative Site, Barakaldo
Medical College of Wisconsin, Milwaukee
Novartis Investigative Site, Samsun
Novartis Investigative Site, Strasbourg
Novartis Investigative Site, Tainan City
Arkansas Childrens Hosp Rsch Inst, Little Rock
Novartis Investigative Site, Freiburg im Breisgau
Novartis Investigative Site, Napoli
Childrens Hospital Los Angeles, Los Angeles
Novartis Investigative Site, Le Kremlin-Bicêtre
Novartis Investigative Site, Lucknow
Novartis Investigative Site, Kolkata
Novartis Investigative Site, Petah Tikva
Novartis Investigative Site, Lo Barnechea
Childrens Hospital of Philadelphia, Philadelphia
Novartis Investigative Site, CABA
Novartis Investigative Site, Curitiba
Novartis Investigative Site, Porto Alegre
Novartis Investigative Site, São Paulo
Novartis Investigative Site, Montreal
Novartis Investigative Site, Montreal
Novartis Investigative Site, Guatemala City
Novartis Investigative Site, New Delhi
Novartis Investigative Site, Roma
Novartis Investigative Site, Riga
Novartis Investigative Site, Mexico City
Novartis Investigative Site, Mexico City
Novartis Investigative Site, Gdansk
Novartis Investigative Site, Lodz
Novartis Investigative Site, Poznan
Novartis Investigative Site, Warsaw
Novartis Investigative Site, Coimbra
Novartis Investigative Site, Lisbon
Novartis Investigative Site, Bratislava
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY