Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

This study is investigating a new medication called BIIB017 for young people aged 10 to 18 who have relapsing-remitting multiple sclerosis (RRMS). The main goals are to understand how safe the drug is and if children and teenagers can tolerate it without too many side effects. Researchers are also looking at how well BIIB017 works to manage MS symptoms and how the body uses and gets rid of the drug. The study has two parts. The first part focuses on assessing safety, tolerability, and initial effectiveness. The second part then follows participants for a longer time to further check long-term safety and how well the treatment helps with MS over many months. This research aims to provide a better understanding of potential new treatments for young people with this condition.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Biogen

Enrolment target

152

Start

18 Oct 2019

Estimated completion

20 May 2027

Multiple Sclerosis, Relapsing-Remitting

What is this study about?

This research is looking into a potential new treatment for young people, specifically those aged 10 to 18, who have a type of multiple sclerosis called relapsing-remitting MS (RRMS). MS is a condition that affects the brain and spinal cord. In RRMS, people experience periods of new or worsening symptoms (called relapses) followed by periods of recovery.

The study is testing a medication known as BIIB017, which is a modified version of an existing MS drug. The main reasons for conducting this study are to find out if BIIB017 is safe for young people, how well their bodies handle the drug, and if it helps manage their MS symptoms. Researchers also want to understand how the body processes the medication in this age group.

This study is split into two phases. In the first phase, participants will receive the treatment, and doctors will carefully monitor their safety, any side effects, and how well the drug seems to be working. In the second, longer phase, participants who completed the first part will continue to be followed. This allows researchers to gather more information on the drug's long-term safety and how it affects MS over a longer period, helping us understand its full potential.

Key takeaways

This study is for young people (10-18) with relapsing-remitting MS.
It tests a new medication called BIIB017 for safety and effectiveness.
Participants will have regular check-ups and MRI scans.
The study has two parts, focusing on initial treatment and long-term follow-up.
Your health and safety will be closely monitored throughout.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, young people between 10 and 18 years old must have a diagnosed type of multiple sclerosis called relapsing-remitting MS. Their MS must also be active, meaning they've had at least one relapse in the last year, or two relapses in the last two years, or have signs of MS activity on a brain scan, even if they haven't had recent symptoms.

There are also some reasons why someone might not be able to join. For example, if they have a different type of MS (like primary or secondary progressive MS), have severe allergies, or have had a relapse very recently (within 30 days of the study starting). Also, if they have ever taken a very specific type of MS medication called PEGylated human IFN β-1a before, they won't be able to participate. The study team will carefully check all these details to make sure it's safe and appropriate for everyone involved.

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 18 years old?
Have you been diagnosed with relapsing-remitting MS?
Have you had at least one MS relapse in the last year, or two in the last two years, or signs of MS activity on a recent brain scan?
Do you not have a different type of MS (like progressive MS)?
Have you never taken a specific type of MS drug similar to BIIB017 before?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking a specific medication called BIIB017. You will have regular visits to the clinic where doctors and nurses will monitor your health very closely. These visits will involve physical examinations, blood tests, and MRI scans of your brain to check for any changes related to your MS. They will also ask you about any symptoms you're experiencing and how you're feeling.

The study is divided into two main parts. The first part lasts for about 96 weeks (around 1 year and 10 months). During this time, you will receive the study medication and attend regular appointments. If you complete this first part safely and as planned, you'll then have the option to enter the second, longer part of the study. This second part continues to assess your safety and how your MS is progressing over an extended period. The total duration of your involvement could therefore be several years, depending on how long the second part runs.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new and closely monitored treatment for your MS and contributing to important research that might help other young people with the condition in the future. However, like all medications, BIIB017 may have side effects, which the study team will explain in detail. There's also the possibility that the treatment may not work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (65)

UC San Diego Health
Verified postcode
La Jolla, United States
UNC Hospitals
Verified postcode
Chapel Hill, United States
Meridian Clinical Research
Verified postcode
Norfolk, United States
Hospital Italiano de Buenos Aires
Approximate
Ciudad Autonoma Buenos Aires, Argentina
Royal Children's Hospital
Verified postcode
Parkville, Australia
Universitair Ziekenhuis Ghent
Verified postcode
Ghent, Belgium
Clinique CHC MontLégia
Verified postcode
Liège, Belgium
MHATNP 'Sv.Naum', EAD
Verified postcode
Sofia, Bulgaria
University Hospital Centre Split
Verified postcode
Split, Croatia
Children's Hospital Zagreb
Verified postcode
Zagreb, Croatia
Clinical Hospital Center 'Sestre Milosrdnice'
Verified postcode
Zagreb, Croatia
University Hospital Centre Zagreb
Verified postcode
Zagreb, Croatia

Common questions

What type of MS is this study for?

This study is specifically for young people with relapsing-remitting multiple sclerosis (RRMS).

What is BIIB017?

BIIB017 is a new experimental medication being tested to see if it can help manage relapsing-remitting MS in young people. It's similar to an existing MS drug.

How old do I need to be to join?

Participants must be between 10 and 18 years old.

Will I get regular check-ups during the study?

Yes, you'll have regular visits, including physical exams, blood tests, and MRI scans, to monitor your health and MS.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.