Last Update: Jul 09, 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.

Multiple Sclerosis (MS)
Phase3
Recruiting
120
Oct 05, 2021
Dec 23, 2031
All
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

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