Active not recruitingPHASE3INTERVENTIONAL

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

This study is for children and teenagers aged 10-17 who have multiple sclerosis (MS). It's designed to compare two new treatments, ofatumumab and siponimod, with an existing treatment called fingolimod. Doctors want to see how safe and effective these new medicines are for young people with MS. The study will last for up to 7 years. Participants will be closely monitored, and their health will be regularly checked throughout the study to understand the long-term effects of these treatments. The goal is to find better ways to manage MS in younger patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

129

Start

05 Oct 2021

Estimated completion

28 Feb 2031

Multiple Sclerosis (MS)

What is this study about?

This research study is looking into new treatments for Multiple Sclerosis (MS) in children and teenagers. MS is a condition that affects your brain and spinal cord, and it can cause a range of symptoms. Finding effective and safe treatments, especially for young people, is really important.

In this study, doctors want to see how well two newer medicines, called ofatumumab and siponimod, work compared to a medicine that's already used for MS, called fingolimod. They will also be looking carefully at the safety of all these medicines. The main aim is to understand if these new options could be a good choice for young people with MS.

This study is part of a bigger process to make sure medicines are safe and effective before they are widely used. By taking part, you could be helping doctors learn more about MS and how best to treat it in young people, potentially improving care for many others in the future.

Key takeaways

This study compares two new MS medicines (ofatumumab, siponimod) to an existing one (fingolimod) for young people.
It's for children and teenagers aged 10 to 17 with MS.
The study lasts up to 7 years and involves regular doctor visits and tests.
Participants will be randomly assigned a treatment, and some won't know which one they receive for the first two years.
The main goals are to check how safe and effective these medicines are for young people with MS.

Who may be eligible?

To join this study, you need to be a child or teenager diagnosed with Multiple Sclerosis (MS) and be between 10 and 17 years old. Your doctor will check your MS symptoms to make sure you've had some recent activity, like a relapse or new changes seen on a brain scan, but that your MS isn't the rapidly worsening type.

There are also some health conditions that would prevent you from taking part. For example, if you have other serious immune system problems (apart from MS), certain heart issues, severe kidney problems, or another condition called ADEM, this study might not be suitable for you. The doctors will do a full health check to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 10 and 17 years old?
Do you have a diagnosis of Multiple Sclerosis (MS)?
Have you had at least one MS relapse or new changes on a brain scan in the last year or two?
Do you *not* have other serious immune problems or serious heart/kidney conditions?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study could last for up to 7 years. For the first two years, called the 'Core Part', you will be randomly assigned to receive one of the study medicines: ofatumumab, siponimod, or fingolimod. You won't know which one you are getting, and neither will your doctor, to make sure the results are fair. You'll switch between taking the actual medication and a 'dummy' pill (placebo) at different times, so everyone thinks they are getting the same thing.

After these first two years, if you complete this part and meet certain criteria, you might be able to continue in the 'Extension Part' for another 5 years. During this time, you would know which active study medicine you are taking. Throughout the study, you'll have regular hospital visits, check-ups, blood tests, and scans to monitor your health and see how the treatment is working. There will be at least 6 months of follow-up for everyone after finishing their treatment.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving close medical attention and access to new treatments that might help manage your MS. However, there are also potential risks related to the medicines being tested, including side effects that your doctor will discuss with you. You might need to attend more appointments than usual, and there's no guarantee the treatment will work for you. It's really important to remember that joining is completely your choice, and you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (51)

Arkansas Childrens Hosp Rsch Inst
Verified postcode
Little Rock, United States
Childrens Hospital Los Angeles
Verified postcode
Los Angeles, United States
Childrens National Medical Center
Verified postcode
Washington D.C., United States
Axiom Clinical Research of Florida
Verified postcode
Tampa, United States
Childrens Hospital of Philadelphia
Verified postcode
Philadelphia, United States
Medical College of Wisconsin
Verified postcode
Milwaukee, United States
Novartis Investigative Site
City only
CABA, Argentina
Novartis Investigative Site
Verified postcode
Parkville, Australia
Novartis Investigative Site
Verified postcode
Vienna, Austria
Novartis Investigative Site
Verified postcode
Esneux, Belgium
Novartis Investigative Site
Verified postcode
Ghent, Belgium
Novartis Investigative Site
Verified postcode
Curitiba, Brazil

Common questions

What is Multiple Sclerosis (MS)?

MS is a condition that affects your brain and spinal cord, which can lead to various symptoms like tiredness, problems with balance, or changes in vision.

Will I know which medicine I am getting?

For the first two years, neither you nor your doctors will know which of the three medicines you are receiving. After that, if you continue, you will know which active drug you are taking.

How long will the study last?

The study could last for up to 7 years in total, with an initial 2-year part followed by an optional 5-year part.

What if I want to leave the study early?

You are free to leave the study at any time, for any reason, and this will not affect your regular medical care.

Are these medicines new?

Ofatumumab and siponimod are newer medicines, and doctors are studying how well they work and their safety in young people with MS compared to an existing treatment, fingolimod.