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Sphingosine-1-Phosphate Receptor Modulator

Ofatumumab + Siponimod vs Fingolimod for Pediatric Multiple Sclerosis (NEOS Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Between 10 to <18 years of age at randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose month 3, 5 and month 12
Awards & highlights

NEOS Trial Summary

This trial showed that ofatumumab and siponimod are more effective and safer than fingolimod in treating multiple sclerosis in children.

Who is the study for?
This trial is for children and teenagers aged 10 to less than 18 with multiple sclerosis (MS). They should have had at least one MS attack in the past year or two attacks in the last two years, or new brain lesions on MRI within a year. Those with progressive MS, other immune diseases, severe heart or kidney problems can't join.Check my eligibility
What is being tested?
The study tests Ofatumumab and Siponimod against Fingolimod, all drugs for MS. Participants will be randomly assigned to receive either one of these drugs or their placebos to compare effectiveness and safety.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, infections due to weakened immune response, liver issues, high blood pressure, breathing difficulties, and potential heart problems. Each drug has its own profile of possible side effects.

NEOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had at least one MS flare-up in the last year or two in the last two years, or new brain lesions.
Select...
I am between 10 and 17 years old.

NEOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose month 3, 5 and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose month 3, 5 and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized relapse rate (ARR) in target pediatric participants
Secondary outcome measures
Annualized T2 lesion rate
Annualized relapse rate (ARR) as compared to historical interferon β-1a data
Neurofilament light chain (NfL) concentrations
+5 more

NEOS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: siponimod - 0.5 mg, 1 mg or 2 mg/ placeboExperimental Treatment2 Interventions
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).
Group II: ofatumumab - 20 mg injection/ placeboExperimental Treatment2 Interventions
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).
Group III: fingolimod - 0.5 mg or 0.25 mg/ placeboActive Control2 Interventions
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siponimod
2019
Completed Phase 3
~190
Ofatumumab
2013
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,525 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
51,947 Patients Enrolled for Multiple Sclerosis

Media Library

Fingolimod (Sphingosine-1-Phosphate Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04926818 — Phase 3
Multiple Sclerosis Research Study Groups: siponimod - 0.5 mg, 1 mg or 2 mg/ placebo, fingolimod - 0.5 mg or 0.25 mg/ placebo, ofatumumab - 20 mg injection/ placebo
Multiple Sclerosis Clinical Trial 2023: Fingolimod Highlights & Side Effects. Trial Name: NCT04926818 — Phase 3
Fingolimod (Sphingosine-1-Phosphate Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04926818 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other drugs that have a similar chemical structure to Siponimod?

"Siponimod was first studied a decade ago at National Institutes of Health Clinical Center. Since the initial study, there have been a total of 125 completed clinical trials. There are presently 32 active studies happening across the world, with a large concentration in Atlanta, Georgia."

Answered by AI

What is the age range of patients that are able to enroll in this research project?

"According to the eligibility requirements, participants must be aged between 10 and 17."

Answered by AI

What are the primary Siponimod indications?

"Siponimod is used to treat leukemia and other disorders like multiple sclerosis. When patients are unresponsive to fludarabine and alemtuzumab or ineligible for fludarabine-based therapy, siponimod can be an effective treatment option."

Answered by AI

Are there numerous sites running this experiment in America?

"To make participating in this clinical trial as convenient as possible for enrollees, it is being run out of 8 different centres located in cities across America, such as Atlanta, Salt Lake City and San Diego."

Answered by AI

What is the known risk profile for Siponimod?

"Siponimod has been evaluated for safety in Phase 3 trials, meaning that there is some evidence to support its efficacy as well as multiple rounds of data to support its safety. Our team at Power has estimated the safety of Siponimod to be a 3 on a scale from 1 to 3."

Answered by AI

Can members of the public still sign up for this clinical trial?

"Yes, the latest information from clinicaltrials.gov shows that this study is still open for recruitment. The trial was created on 10/5/2021, and the most recent update was on 10/4/2022. A total of 180 participants are needed, and there are currently 8 sites enrolling patients."

Answered by AI

If I qualify, can I take part in this experiment?

"This particular medical trial is open to 180 patients that are aged 10-17 and have a diagnosis of multiple sclerosis. Aside from meeting this age and disease criteria, potential participants must also have an Expanded Disability Status Scale (EDSS) score of 0-5.5 and have had either one relapse in the past year or two relapses in the past two years. Lastly, there must be evidence of one or more new T2 lesions within the past 12 months."

Answered by AI

Who else is applying?

What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
2021. "Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04926818.
All > Primary Progressive Multiple Sclerosis > Multiple Sclerosis
~85 spots leftby Aug 2026
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