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

PHASE3RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 10 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-10-05

Primary completion: 2027-03-02

Study completion finish: 2031-12-23

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04926818

Intervention or treatment

DRUG: Fingolimod

DRUG: Ofatumumab

DRUG: Siponimod

OTHER: Fingolimod placebo

OTHER: Siponimod placebo

OTHER: Ofatumumab placebo

Conditions

• Multiple Sclerosis (MS)

Image related to Multiple Sclerosis (MS)

Condition: Multiple Sclerosis (MS)
DRUG: Fingolimod and other drugs
Parkville, Victoria, Australia
Sponsor: Novartis Pharmaceuticals

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Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Parkville, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ofatumumab - 20 mg injection/ placebo 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: 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).
EXPERIMENTAL: siponimod - 0.5 mg, 1 mg or 2 mg/ placebo 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).	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).
ACTIVE_COMPARATOR: fingolimod - 0.5 mg or 0.25 mg/ placebo 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: 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).

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Annualized relapse rate (ARR) in target pediatric participants	Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).	Baseline up to 24 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Annualized relapse rate (ARR) as compared to historical interferon β-1a data	Frequency of relapses assessed by the annualized relapse rate (ARR) to historical interferon β-1a data. The ARR is defined as the average number of confirmed relapses per year. The historical data for interferon β-1a will derived from prior phase 3 studies.	Baseline up to 24 months
Annualized T2 lesion rate	Number of new/newly enlarged T2 lesions per year	Baseline up to 24 months
Neurofilament light chain (NfL) concentrations	Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod	Day 1, Months 3,6,12,18,24
Plasma Concentrations of ofatumumab	Ofatumumab plasma concentrations	Day 1, pre-dose for Day 7, Months 2,3,5,6,12,18,24
Plasma Concentrations of siponimod	Siponimod plasma concentrations	Day 1 (2,3,4,6 h), Day 3 (2,3,4,6 h), pre-dose for Months 1 (pre, 3h), 3,5,12
Plasma Concentrations of siponimod metabolite (M17)	Siponimod metabolite (M17) plasma concentration	Pre-dose Month 3, 5 and Month 12
Percentage of participants with anti-ofatumumab antibodies	Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab	Day 1, Pre-Dose Months 2,3,5,6,12,18,24
Number of adverse events and serious adverse events	Any clinically relevant finding that meets the criteria of an adverse event (as determined by the investigator) identified during the safety assessments (ECG, laboratory and ophthalmological data, pulmonary function tests and vital signs) will be reported as an adverse event	Baseline up approximately 66 months

Frequently Asked Questions

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References

Clinical Trials Gov: Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis