Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
NCT ID: NCT04926818
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
129 participants
INTERVENTIONAL
2021-10-05
2031-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ofatumumab - 20 mg injection/ placebo
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).
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).
Ofatumumab placebo
Ofatumumab matching placebo autoinjector
siponimod - 0.5 mg, 1 mg or 2 mg/ placebo
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).
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).
Siponimod placebo
Siponimod matching placebo tablet
fingolimod - 0.5 mg or 0.25 mg/ placebo
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
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).
Fingolimod placebo
Fingolimod matching placebo capsule
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of multiple sclerosis
3. EDSS score of 0 to 5.5, inclusive
4. 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
Exclusion Criteria
2. Participants with an active, chronic disease of the immune system other than MS
3. Participants meeting the definition of ADEM
4. Participants with severe cardiac disease or significant findings on the screening ECG.
5. Participants with severe renal insufficiency
10 Years
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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, Buenos Aires, Argentina
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Parkville, Victoria, Australia
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Vienna, , Austria
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Esneux, , Belgium
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Ghent, , Belgium
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Lo Barnechea, Santiago Metropolitan, Chile
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Zagreb, , Croatia
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Tallinn, , Estonia
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Le Kremlin-Bicêtre, , France
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Montpellier, , France
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Strasbourg, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Göttingen, Lower Saxony, Germany
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Bochum, , Germany
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Guatemala City, , Guatemala
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New Delhi, National Capital Territory of Delhi, India
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Lucknow, Uttar Pradesh, India
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Kolkata, West Bengal, India
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Petah Tikva, , Israel
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Roma, RM, Italy
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Napoli, , Italy
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Riga, , Latvia
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Gdansk, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Belgrade, , Serbia
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Bratislava, , Slovakia
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Seville, Andalusia, Spain
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Barakaldo, Vizcaya, Spain
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Samsun, Atakum, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Kocaeli, Izmit, Turkey (Türkiye)
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Izmir, Karsiyaka, Turkey (Türkiye)
Countries
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Other Identifiers
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CBAF312D2301
Identifier Type: -
Identifier Source: org_study_id
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