Multiple Sclerosis Clinical Trial

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

Summary

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

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Full Description

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 180 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.

View Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

180

Study ID:

NCT04926818

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 73 Locations for this study

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Arkansas Childrens Hosp Rsch Inst .
Little Rock Arkansas, 72202, United States More Info
Kat Turbeville
Contact
+1 501 978 6413
[email protected]
Virginia Erin Willis
Principal Investigator
Childrens Hospital Los Angeles .
Los Angeles California, 90027, United States More Info
Fatima Menendez
Contact
401-413-2344
[email protected]
Jonathan Santoro
Principal Investigator
University of California San Diego
San Diego California, 92103, United States More Info
Sophie Zacharek
Contact
619-543-6102
[email protected]
Jennifer Graves
Principal Investigator
Children's National Medical Center .
Washington District of Columbia, 20010, United States More Info
Emily Mc Cracken
Contact
202-476-5000
[email protected]
Alexandra Kornbluh
Principal Investigator
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States More Info
Haitham Abulaban
Contact
813-353-9613
[email protected]
Mark Cascione
Principal Investigator
Childrens Healthcare of Atlanta Egleston .
Atlanta Georgia, 30329, United States More Info
Arpit Dosanjh
Contact
404-785-5437
[email protected]
Grace Gombolay
Principal Investigator
Uni of Louisville Clncl Trials Unit Novak Center
Louisville Kentucky, 40202, United States More Info
Michael Sweeney
Principal Investigator
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States More Info
Lexi DeLay
Contact
507-284-5689
[email protected]
Jan-Mendelt Tillema
Principal Investigator
Washington Uni School of Med Main Center
Saint Louis Missouri, 63110, United States More Info
Olga Novak
Contact
314-454-8293
[email protected]
Soe Mar
Principal Investigator
Providence St Vincent Med Center .
Portland Oregon, 97225, United States More Info
Contact
503-216-1234
Alison Christy
Principal Investigator
Childrens Hospital of Philadelphia .
Philadelphia Pennsylvania, 19104, United States More Info
Kat Gallison
Contact
215-590-1719
[email protected]
Amy Waldman
Principal Investigator
University of Texas Southwestern Main Center
Dallas Texas, 75390, United States More Info
Tammy Ramm
Contact
214-648-2546
[email protected]
Cynthia Wang
Principal Investigator
The University of Utah Health Image and Neurosciences
Salt Lake City Utah, 84132, United States
West Virginia University Cardio
Morgantown West Virginia, 26506, United States More Info
Tricia Swiger
Contact
855-988-2273
[email protected]
Jodi Lindsey
Principal Investigator
Medical College of Wisconsin .
Milwaukee Wisconsin, 53226, United States More Info
Adriane Mueller
Contact
414-955-0619
[email protected]
Ahmed Obeidat
Principal Investigator
Novartis Investigative Site
Caba Buenos Aires, C1181, Argentina
Novartis Investigative Site
Parkville Victoria, 3052, Australia
Novartis Investigative Site
Vienna , 1090, Austria
Novartis Investigative Site
Esneux , 4130, Belgium
Novartis Investigative Site
Gent , 9000, Belgium
Novartis Investigative Site
Curitiba PR, 81210, Brazil
Novartis Investigative Site
Porto Alegre RS, 90430, Brazil
Novartis Investigative Site
Sao Paulo SP, 05403, Brazil
Novartis Investigative Site
Toronto Ontario, M5G 1, Canada
Novartis Investigative Site
Montreal Quebec, H3A 2, Canada
Novartis Investigative Site
Montreal Quebec, H3T 1, Canada
Novartis Investigative Site
Lo Barnechea Santiago, 76912, Chile
Novartis Investigative Site
Zagreb , 10000, Croatia
Novartis Investigative Site
Tallinn , 11315, Estonia
Novartis Investigative Site
Le Kremlin Bicetre , 94275, France
Novartis Investigative Site
Montpellier , 34295, France
Novartis Investigative Site
Strasbourg , 67098, France
Novartis Investigative Site
Berlin , 13353, Germany
Novartis Investigative Site
Bochum , 44791, Germany
Novartis Investigative Site
Erlangen , 91054, Germany
Novartis Investigative Site
Freiburg , 79106, Germany
Novartis Investigative Site
Gottingen , 37075, Germany
Novartis Investigative Site
Guatemala , 01015, Guatemala
Novartis Investigative Site
New Delhi Delhi, 110 0, India
Novartis Investigative Site
New Delhi Delhi, 11001, India
Novartis Investigative Site
Kochi Kerala, 68204, India
Novartis Investigative Site
Lucknow Uttar Pradesh, 22601, India
Novartis Investigative Site
Kolkata West Bengal, 70001, India
Novartis Investigative Site
Petach-Tikva , 49202, Israel
Novartis Investigative Site
Milano MI, 20132, Italy
Novartis Investigative Site
Roma RM, 00165, Italy
Novartis Investigative Site
Napoli , 80131, Italy
Novartis Investigative Site
Riga , LV-10, Latvia
Novartis Investigative Site
Ciudad de Mexico Distrito Federal, 06700, Mexico
Novartis Investigative Site
Mexico Distrito Federal, 06720, Mexico
Novartis Investigative Site
Chihuahua , 31203, Mexico
Novartis Investigative Site
Gdansk , 80 95, Poland
Novartis Investigative Site
Lodz , 93-33, Poland
Novartis Investigative Site
Poznan , 60-35, Poland
Novartis Investigative Site
Warsaw , 04 73, Poland
Novartis Investigative Site
Coimbra , 3000-, Portugal
Novartis Investigative Site
Lisboa , 1169-, Portugal
Novartis Investigative Site
Bucuresti , 04191, Romania
Novartis Investigative Site
St Petersburg , 19000, Russian Federation
Novartis Investigative Site
Belgrade , 11000, Serbia
Novartis Investigative Site
Bratislava , 833 4, Slovakia
Novartis Investigative Site
Sevilla Andalucia, 41009, Spain
Novartis Investigative Site
Oviedo Asturias, 33011, Spain
Novartis Investigative Site
Baracaldo Vizcaya, 48903, Spain
Novartis Investigative Site
Kaohsiung , 83301, Taiwan
Novartis Investigative Site
Tainan , 70403, Taiwan
Novartis Investigative Site
Taipei , 10002, Taiwan
Novartis Investigative Site
Istanbul TUR, 34098, Turkey
Novartis Investigative Site
Izmir , 35340, Turkey
Novartis Investigative Site
Izmir , 35575, Turkey
Novartis Investigative Site
Kocaeli , 41380, Turkey
Novartis Investigative Site
Samsun , 55139, Turkey
Novartis Investigative Site
London , WC1N , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

180

Study ID:

NCT04926818

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

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