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

A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

ClinicalTrials.gov Identifier: NCT04926818

Novartis Reference Number: CBAF312D2301

Last Update: Nov 17, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Multiple Sclerosis (MS)
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Oct 05, 2021
Completion date 
Jun 01, 2029
Gender 
All
Age(s)
10 Years - 17 Years (Child)

Interventions

Drug
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).
Drug
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).
Drug
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).
Other
Fingolimod placebo
Fingolimod matching placebo capsule
Other
Siponimod placebo
Siponimod matching placebo tablet
Other
Ofatumumab placebo
Ofatumumab matching placebo autoinjector

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Little Rock, 72202
Arkansas
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90027
California
United States
Novartis Investigative Site
Recruiting
San Diego, 92103
California
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30329
Georgia
United States
Novartis Investigative Site
Recruiting
Portland, 97225
Oregon
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84132
Utah
United States
Novartis Investigative Site
Recruiting
Milwaukee, 53226
Wisconsin
United States
Australia
Novartis Investigative Site
Recruiting
Parkville, 3052
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Vienna, 1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Esneux, 4130
-
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Curitiba, 81210-310
PR
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90430-001
RS
Brazil
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1X8
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H3A 2B4
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1C5
Quebec
Canada
Chile
Novartis Investigative Site
Recruiting
Santiago,
-
Chile
Croatia
Novartis Investigative Site
Recruiting
Zagreb,
-
Croatia
Estonia
Novartis Investigative Site
Recruiting
Tallinn, 11315
-
Estonia
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Novartis Investigative Site
Recruiting
Montpellier, 34295
-
France
Novartis Investigative Site
Recruiting
Strasbourg, 67098
-
France
Germany
Novartis Investigative Site
Recruiting
Bochum, 44791
-
Germany
Novartis Investigative Site
Recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Guatemala
Novartis Investigative Site
Recruiting
Guatemala, 01015
-
Guatemala
India
Novartis Investigative Site
Recruiting
New Delhi, 110 060
Delhi
India
Novartis Investigative Site
Recruiting
New Delhi, 110017
Delhi
India
Novartis Investigative Site
Recruiting
Lucknow, 226014
Uttar Pradesh
India
Novartis Investigative Site
Recruiting
Kolkata, 700017
West Bengal
India
Israel
Novartis Investigative Site
Recruiting
Petach-Tikva, 49202
-
Israel
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Roma, 00165
RM
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Latvia
Novartis Investigative Site
Recruiting
Riga, LV-1004
-
Latvia
Mexico
Novartis Investigative Site
Recruiting
Ciudad de Mexico, 06700
Distrito Federal
Mexico
Novartis Investigative Site
Recruiting
Chihuahua, 31203
-
Mexico
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80 952
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 93-338
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-355
-
Poland
Novartis Investigative Site
Recruiting
Warsaw, 04 730
-
Poland
Portugal
Novartis Investigative Site
Recruiting
Coimbra, 3000-602
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1169-050
-
Portugal
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 190000
-
Russian Federation
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 833 40
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Baracaldo, 48903
Vizcaya
Spain
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung City, 83301
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35340
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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