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

Last Update: Jun 18, 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 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.

Condition

Multiple Sclerosis (MS)

Phase

Phase3

Overall Status

Recruiting

Number of Participants

120

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:

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

Study Location

Novartis Investigative Site

Recruiting

Caba,Buenos Aires,C1181ach,Argentina

Novartis Investigative Site

Recruiting

Parkville,Victoria,3052,Australia

Novartis Investigative Site

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Vienna,1090,Austria

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Esneux,4130,Belgium

Novartis Investigative Site

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Gent,9000,Belgium

Novartis Investigative Site

Recruiting

Porto Alegre,RS,90430-001,Brazil

Novartis Investigative Site

Recruiting

Curitiba,PR,81210-310,Brazil

Novartis Investigative Site

Recruiting

Sao Paulo,SP,05403-000,Brazil

Novartis Investigative Site

Recruiting

Montreal,Quebec,H3t 1c5,Canada

Novartis Investigative Site

Recruiting

Toronto,Ontario,M5g 1x8,Canada

Novartis Investigative Site

Recruiting

Montreal,Quebec,H3a 2b4,Canada

Novartis Investigative Site

Recruiting

Lo Barnechea,Santiago,7691236,Chile

Novartis Investigative Site

Recruiting

Zagreb,10000,Croatia

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Recruiting

Tallinn,11315,Estonia

Novartis Investigative Site

Recruiting

Le Kremlin Bicetre,94275,France

Novartis Investigative Site

Recruiting

Strasbourg,67098,France

Novartis Investigative Site

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Montpellier,34295,France

Novartis Investigative Site

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Bochum,44791,Germany

Novartis Investigative Site

Recruiting

Gottingen,37075,Germany

Novartis Investigative Site

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Erlangen,91054,Germany

Novartis Investigative Site

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Freiburg,79106,Germany

Novartis Investigative Site

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Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Guatemala,01015,Guatemala

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

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Recruiting

New Delhi,Delhi,110017,India

Novartis Investigative Site

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Petach Tikva,49202,Israel

Novartis Investigative Site

Recruiting

Napoli,80131,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20132,Italy

Novartis Investigative Site

Recruiting

Roma,RM,00165,Italy

Novartis Investigative Site

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Riga,Lv-1004,Latvia

Novartis Investigative Site

Recruiting

Mexico,Distrito Federal,06720,Mexico

Novartis Investigative Site

Recruiting

Chihuahua,31203,Mexico

Novartis Investigative Site

Recruiting

Ciudad de Mexico,Distrito Federal,06700,Mexico

Novartis Investigative Site

Recruiting

Poznan,60-355,Poland

Novartis Investigative Site

Recruiting

Warsaw,04 730,Poland

Novartis Investigative Site

Recruiting

Gdansk,80 952,Poland

Novartis Investigative Site

Recruiting

Lodz,93-338,Poland

Novartis Investigative Site

Recruiting

Coimbra,3000-602,Portugal

Novartis Investigative Site

Recruiting

Lisboa,1169-050,Portugal

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Recruiting

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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Sevilla,Andalucia,41009,Spain

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Madrid,28034,Spain

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Oviedo,Asturias,33011,Spain

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Baracaldo,Vizcaya,48903,Spain

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Recruiting

Kaohsiung,83301,Taiwan

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Tainan,70403,Taiwan

Novartis Investigative Site

Recruiting

Taipei,10002,Taiwan

Novartis Investigative Site

Recruiting

Istanbul,TUR,34098,Turkey

Novartis Investigative Site

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Izmir,35575,Turkey

Novartis Investigative Site

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Samsun,55139,Turkey

Novartis Investigative Site

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Kocaeli,41380,Turkey

Novartis Investigative Site

Recruiting

London,Wc1n 1eh,United Kingdom

University of California San Diego

Recruiting

San Diego,California,92103,United States

Childrens Hospital of Philadelphia .

Recruiting

Philadelphia,Pennsylvania,19104 4399,United States

Novartis Investigative Site

Recruiting

Portland,Oregon,97225,United States

University of Texas Southwestern Main Center

Recruiting

Dallas,Texas,75390,United States

Childrens National Medical Center .

Recruiting

Washington,District of Columbia,20010,United States

WA Uni School Of Med Main Center

Recruiting

Saint Louis,Missouri,63110,United States

Mayo Clinic - Rochester

Recruiting

Rochester,Minnesota,55905,United States

Arkansas Childrens Hosp Rsch Inst .

Recruiting

Little Rock,Arkansas,72202,United States

Medical College of Wisconsin .

Recruiting

Milwaukee,Wisconsin,53226,United States

Axiom Clinical Research of Florida

Recruiting

Tampa,Florida,33609,United States

Childrens Healthcare of Atlanta .

Recruiting

Atlanta,Georgia,30329,United States

Uni of Louisville Clncl Trials Unit Novak Center

Recruiting

Louisville,Kentucky,40202,United States

Childrens Hospital Los Angeles .

Recruiting

Los Angeles,California,90027,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]