Study Description
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric
patients with multiple sclerosis 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.
Interventions
Fingolimod
Fingolimod placebo
Ofatumumab
Ofatumumab placebo
Siponimod
Siponimod placebo
Eligibility Criteria
Inclusion Criteria:
1. Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at
randomization
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:
1. Participants with progressive MS
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
Novartis Investigative Site
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Caba,Buenos Aires,C1181ach,Argentina
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Parkville,Victoria,3052,Australia
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Wien,1090,Austria
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Gent,9000,Belgium
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Esneux,4130,Belgium
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Curitiba,PR,81210-310,Brazil
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Porto Alegre,RS,90430-001,Brazil
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Sao Paulo,SP,05403-000,Brazil
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Montreal,Quebec,H3a 2b4,Canada
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Montreal,Quebec,H3t 1c5,Canada
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Lo Barnechea,Santiago,7691236,Chile
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Zagreb,10000,Croatia
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Tallinn,11315,Estonia
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Le Kremlin Bicetre,94275,France
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Montpellier,34295,France
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Strasbourg,67000,France
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Bochum,44791,Germany
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Erlangen,91054,Germany
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Freiburg,79106,Germany
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Gottingen,37075,Germany
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Berlin,13353,Germany
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Guatemala,01015,Guatemala
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Lucknow,Uttar Pradesh,226014,India
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Kolkata,West Bengal,700017,India
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New Delhi,Delhi,110 017,India
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Kochi,Kerala,682041,India
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Petach Tikva,49202,Israel
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Milano,MI,20132,Italy
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Roma,RM,00165,Italy
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Napoli,80131,Italy
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Riga,Lv-1004,Latvia
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Ciudad de Mexico,Distrito Federal,06700,Mexico
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Mexico,Distrito Federal,06720,Mexico
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Poznan,60-355,Poland
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Gdansk,80 952,Poland
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Warsaw,04 730,Poland
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Lodz,93-338,Poland
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Coimbra,3000-602,Portugal
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Lisboa,1169 050,Portugal
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Bucuresti,041914,Romania
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Belgrade,11000,Serbia
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Bratislava,833 40,Slovakia
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Sevilla,Andalucia,41009,Spain
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Oviedo,Asturias,33011,Spain
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Baracaldo,Vizcaya,48903,Spain
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Madrid,28034,Spain
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Tainan,70403,Taiwan
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Taipei,10002,Taiwan
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Istanbul,TUR,34098,Turkey
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Izmir,35575,Turkey
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Kocaeli,41380,Turkey
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Samsun,55139,Turkey
Axiom Clinical Research of Florida
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Tampa,Florida,33609,United States
Mark Cascione
Medical College of Wisconsin .
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Milwaukee,Wisconsin,53226,United States
Ahmed Obeidat
Arkansas Childrens Hosp Rsch Inst .
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Little Rock,Arkansas,72202,United States
Virginia Erin Willis
WA Uni School Of Med Main Center
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Saint Louis,Missouri,63110,United States
Soe Mar
Childrens Hospital Los Angeles .
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Los Angeles,California,90027,United States
Jonathan Santoro
Childrens Healthcare Of Atlanta .
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Atlanta,Georgia,30322,United States
Grace Gombolay
Childrens Hospital of Philadelphia .
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Philadelphia,Pennsylvania,19104 4399,United States
Amy Waldman
Uni of Louisville Clncl Trials Unit Novak Center
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Louisville,Kentucky,40202,United States
Michael Sweeney
Childrens National Medical Center .
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Washington,District of Columbia,20010,United States
Alexandra Kornbluh
Mayo Clinic - Rochester
Recruiting
Rochester,Minnesota,55905,United States
Jan-Mendelt Tillema
Worldwide Contacts
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