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

Last Update: Apr 23, 2024

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

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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

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.

Condition

Multiple Sclerosis (MS)

Phase

Phase 3

Overall Status

Recruiting

Number of Participants

180

Start Date

Oct 05, 2021

Completion Date

Dec 23, 2031

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).

Other

Fingolimod placebo

Fingolimod matching placebo capsule

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).

Other

Ofatumumab placebo

Ofatumumab matching placebo autoinjector

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

Siponimod placebo

Siponimod matching placebo tablet

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 Location

Novartis Investigative Site

Recruiting

Caba,Buenos Aires,C1181ACH,Argentina

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Parkville,Victoria,3052,Australia

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Vienna,1090,Austria

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Gent,9000,Belgium

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Esneux,4130,Belgium

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Sao Paulo,SP,05403-000,Brazil

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Porto Alegre,RS,90430-001,Brazil

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Curitiba,PR,81210-310,Brazil

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Montreal,Quebec,H3A 2B4,Canada

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Toronto,Ontario,M5G 1X8,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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Montpellier,34295,France

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Strasbourg,67098,France

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Le Kremlin Bicetre,94275,France

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Freiburg,79106,Germany

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Berlin,13353,Germany

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Bochum,44791,Germany

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Gottingen,37075,Germany

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Erlangen,91054,Germany

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Guatemala,01015,Guatemala

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Kochi,Kerala,682041,India

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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,110017,India

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Petach-Tikva,49202,Israel

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Napoli,80131,Italy

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Roma,RM,00165,Italy

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Milano,MI,20132,Italy

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Riga,LV-1004,Latvia

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Chihuahua,31203,Mexico

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Ciudad de Mexico,Distrito Federal,06700,Mexico

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Mexico,Distrito Federal,06720,Mexico

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Gdansk,80 952,Poland

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Lodz,93-338,Poland

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Poznan,60-355,Poland

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Warsaw,04 730,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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St Petersburg,190000,Russian Federation

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Belgrade,11000,Serbia

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Bratislava,833 40,Slovakia

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Baracaldo,Vizcaya,48903,Spain

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Sevilla,Andalucia,41009,Spain

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Oviedo,Asturias,33011,Spain

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Kaohsiung,83301,Taiwan

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Tainan,70403,Taiwan

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Taipei,10002,Taiwan

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Izmir,35575,Turkey

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Kocaeli,41380,Turkey

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Istanbul,TUR,34098,Turkey

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Samsun,55139,Turkey

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London,WC1N 1EH,United Kingdom

Uni of Louisville Clncl Trials Unit Novak Center

Recruiting

Louisville,Michael Sweeney,40202 - Kentucky,United States

Children's National Medical Center .

Recruiting

Washington,Emily Mc Cracken (202-476-5000) email: [email protected] -- Alexandra Kornbluh,20010 - District of Columbia,United States

University of California San Diego

Recruiting

San Diego,Sophie Zacharek (619-543-6102) email: [email protected] -- Jennifer Graves,92103 - California,United States

Childrens Healthcare of Atlanta .

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Atlanta,Arpit Dosanjh (404-785-5437) email: [email protected] -- Grace Gombolay,30329 - Georgia,United States

University of Texas Southwestern Main Center

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Dallas,Tammy Ramm (214-648-2546) email: [email protected] -- Cynthia Wang,75390 - Texas,United States

Childrens Hospital Los Angeles .

Recruiting

Los Angeles,Fatima Menendez (401-413-2344) email: [email protected] -- Jonathan Santoro,90027 - California,United States

Washington Uni School of Med Main Center

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Saint Louis,Olga Novak (314-454-8293) email: [email protected] -- Soe Mar,63110 - Missouri,United States

Childrens Hospital of Philadelphia .

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Philadelphia,Kat Gallison (215-590-1719) email: [email protected] -- Amy Waldman,19104 4399 - Pennsylvania,United States

Mayo Clinic - Rochester

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Rochester,Lexi DeLay (507-284-5689) email: [email protected] -- Jan-Mendelt Tillema,55905 - Minnesota,United States

Arkansas Childrens Hosp Rsch Inst .

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Little Rock,Kat Turbeville (+1 501 978 6413) email: [email protected] -- Virginia Erin Willis,72202 - Arkansas,United States

Providence St Vincent Med Center .

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Portland,(503-216-1234) -- Alison Christy,97225 - Oregon,United States

Medical College of Wisconsin .

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Milwaukee,Adriane Mueller (414-955-0619) email: [email protected] -- Ahmed Obeidat,53226 - Wisconsin,United States

Axiom Clinical Research of Florida

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Tampa,Fnu Madhuri (813-353-9613) email: [email protected] -- Mark Cascione,33609 - Florida,United States

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Phone: +41613241111

Email:

Novartis Pharmaceuticals

Phone: 1-888-669-6682

Email: [email protected]