Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

This study is an extension of previous research, designed to check the long-term safety and how well people tolerate a medicine called tolebrutinib. It's for adults, aged 18 and over, who have relapsing, secondary progressive, or progressive relapsing multiple sclerosis (MS). All participants in this study would have already been involved in an earlier study looking at tolebrutinib. During this study, participants will receive tolebrutinib, and researchers will continue to monitor their health. The aim is to gather more information about its effects over a longer period. This will help doctors understand more about using tolebrutinib to manage different types of MS.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

2,500

Start

16 Apr 2024

Estimated completion

30 Apr 2029

Relapsing Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

What is this study about?

This study, called a Phase 3 extension study, is a follow-up to earlier research into a medicine known as tolebrutinib. Its main purpose is to carefully check the long-term safety of tolebrutinib and how well people can take it over an extended period. We already have initial information about this medicine from previous trials, but understanding its effects over many years is very important.

The study involves adults (18 years and older) who live with different types of multiple sclerosis (MS): relapsing MS, secondary progressive MS, or progressive relapsing MS. All participants will have already been part of an earlier study involving tolebrutinib. This study will give researchers the chance to continue watching participants who are taking tolebrutinib, or for some, to start taking it, allowing for a much longer period of observation. This helps doctors build a complete picture of the medicine's overall profile.

Learning about the long-term safety and tolerability of any new medicine is crucial. It helps health authorities decide if the medicine is safe and effective enough for wider use, and it gives doctors and patients important information to make informed choices about treatment. By continuing to follow people for a longer time, this study aims to provide valuable insights into how tolebrutinib might help manage MS in the long run.

Key takeaways

This study is for adults with different types of MS who have already taken part in an earlier tolebrutinib study.
The main goal is to understand the long-term safety and how well people tolerate tolebrutinib over about three years.
Participants will receive tolebrutinib and have regular health check-ups.
It helps researchers gather more complete information about the medicine's effects over time.
You have the right to leave the study at any point if you wish.

Who may be eligible?

This study is for adults, aged 18 and over, who have already participated in one of the earlier trials looking at tolebrutinib for multiple sclerosis. This means you would have previously been involved in either the Phase 2b study (LTS16004) or one of the four main Phase 3 studies (GEMINI 1, GEMINI 2, HERCULES, or PERSEUS) where you were given the study medicine.

There are also some reasons why you might not be able to join. For example, if you have a serious ongoing infection, certain liver problems, or if there are concerns about your heart. You also wouldn't be able to join if you have a bleeding disorder, problems with your blood clotting, or a history of drug or alcohol abuse within the last year, or if you drink more than a certain amount of alcohol regularly.

The study team will carefully review your medical history and current health to make sure joining the study is safe for you. It's important to discuss any health conditions or medicines you take with them.

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.

I am 18 years old or older.
I have previously participated in one of the earlier tolebrutinib studies (Phase 2b or one of the Phase 3 trials).
I do not have a serious ongoing infection or certain liver problems.
I do not have a known bleeding disorder or a history of recent drug or alcohol abuse.
My heart health is generally good, without certain significant concerns identified by a doctor.

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for about three years. For some, if you were already taking tolebrutinib in the previous study, you will simply continue taking it. For others, particularly those who were on a different treatment called teriflunomide in the previous study, there might be a short period where you stop that medicine before starting tolebrutinib.

Throughout the study, you'll have regular visits with the study team. These visits will involve health checks, tests, and assessments to see how you are doing and how the medicine is affecting you. The exact number and timing of visits will be explained by the study team. They will also continuously monitor your health to make sure the treatment is safe for you.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is continued access to tolebrutinib, which may help manage your MS. The study also helps gather important long-term safety information which could benefit future patients. Potential risks relate to the medicine itself; while previous studies have looked at safety, long-term side effects are still being monitored. You might experience side effects like changes in liver tests, or an increased risk of infections. The study team will explain all known potential risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (352)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The University of Alabama at Birmingham- Site Number : 8400013
Verified postcode
Birmingham, United States
~North Central Neurology Associates, PC- Site Number : 8400009
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Cullman, United States
Center for Neurology and Spine- Site Number : 8400089
Verified postcode
Phoenix, United States
Collaborative Neuroscience Research- Site Number : 8400045
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Los Alamitos, United States
USC- Site Number : 8400143
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Los Angeles, United States
University of California San Diego Medical Center- Site Number : 8400101
Verified postcode
San Diego, United States
Regina Berkovich, MD, PhD- Site Number : 8400059
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West Hollywood, United States
University of Colorado- Site Number : 8400012
Verified postcode
Denver, United States
Advanced Neurosciences Research- Site Number : 8400025
Verified postcode
Fort Collins, United States
Georgetown University Medical Center- Site Number : 8400119
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Washington D.C., United States
SFM Clinical Research, LLC- Site Number : 8400029
Verified postcode
Boca Raton, United States
University of Florida Health- Site Number : 8400159
Verified postcode
Gainesville, United States

Common questions

What is tolebrutinib?

Tolebrutinib is a medicine being studied for multiple sclerosis. This study is looking at its effects over a longer period.

Who can join this study?

Only adults (18+) who have already been in a previous tolebrutinib study for MS can join this long-term follow-up.

How long will I be in the study?

Your involvement in this study will be for about three years.

Will I know which medicine I'm taking?

Yes, in this study, you will know that you are taking tolebrutinib, as it's an 'open-label' study.

What does 'long-term safety' mean?

It means the study is focused on understanding how safe the medicine is and if there are any side effects that appear over many months or years.