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