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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis (MS)

In brief

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

Key facts

Study ID

NCT04926818

Run by

Novartis Pharmaceuticals

People needed

129

Starts

2021-10-05

Expected to finish

2031-02-28

Last updated by the study team

2026-05-14

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Arkansas Childrens Hosp Rsch Inst — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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