In short
There are currently 2 ongoing clinical trials investigating treatments for progressive relapsing multiple sclerosis. Both studies are exploring the long-term safety and tolerability of tolebrutinib, an investigational medication designed to reduce inflammation and nerve damage in people with various forms of multiple sclerosis, including relapsing and progressive types.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Croatia
- Czechia
- Denmark
- Espagne
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Spain
- Sweden
Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis
This clinical trial is designed to evaluate the long-term safety of tolebrutinib, an investigational medication for people with different forms of multiple sclerosis. The study includes participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, and nonrelapsing secondary progressive multiple sclerosis.
Main inclusion criteria: To participate in this study, individuals must have one of the specified types of multiple sclerosis and must have already completed a previous Phase 2b or Phase 3 clinical trial involving tolebrutinib. This ensures that participants have prior experience with the medication. Both men and women are eligible, including those from vulnerable populations who may require extra care or protection. Even participants who had to temporarily stop taking the medication due to a national emergency can join, as long as they completed their trial visits.
Main exclusion criteria: People with other serious health conditions that could interfere with the study are not eligible. This includes individuals currently participating in another clinical trial, those with recent infections requiring treatment, or those who have received recent vaccinations within a specific timeframe. People with a history of certain cancers, those who are pregnant or breastfeeding, and individuals with a history of drug or alcohol abuse are also excluded. Additionally, anyone who has had an allergic reaction to similar medications or has conditions affecting their ability to understand or follow study instructions cannot participate.
Study focus: The main goal of this trial is to understand how safe and well-tolerated tolebrutinib is when taken over several years. Researchers will monitor participants for any side effects or unwanted health events that may occur during treatment. The study will also track changes in participants' conditions, such as whether their disability gets worse or if they experience relapses. Regular assessments and imaging tests, such as MRI scans, will be used to monitor changes in the brain and nervous system. The study is expected to continue until August 2029.
Investigational drug: The medication being tested is tolebrutinib, which comes in the form of film-coated tablets taken orally. Tolebrutinib works by inhibiting Bruton's tyrosine kinase, a protein involved in the immune system's activity. By blocking this protein, tolebrutinib may help reduce inflammation and prevent nerve damage. Some participants may also receive teriflunomide (marketed as Aubagio) or a placebo for comparison purposes.
Study on Long-Term Safety of Tolebrutinib for Patients with Relapsing or Progressive Multiple Sclerosis
This trial focuses on the long-term safety and tolerability of tolebrutinib in people with various forms of multiple sclerosis, including relapsing, primary progressive, and nonrelapsing secondary progressive types.
Main inclusion criteria: Participants must have a diagnosis of relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis. They should have completed a previous Phase 2b or one of four specific Phase 3 trials involving tolebrutinib. Both men and women can participate, and the study includes individuals from vulnerable populations. Those who temporarily discontinued the medication due to a national emergency but completed their trial visits are also eligible.
Main exclusion criteria: Individuals with certain nervous system diseases beyond the types of multiple sclerosis specified may not be eligible. People who do not meet the age requirements or cannot follow study procedures are excluded. Other reasons for exclusion include having medical conditions that might interfere with the study, being pregnant or breastfeeding, currently participating in another clinical trial, having had recent major surgery or planning surgery during the study, having a history of allergic reactions to the study medication, certain infections or diseases that could affect results, or a history of substance abuse.
Study focus: This study aims to determine how safe tolebrutinib is over an extended period of up to 36 months. Researchers will carefully monitor participants for any unwanted effects or adverse events throughout the study. The trial will also assess how the medication affects disability progression and will use MRI scans to track any changes in the brain. Additional substances used in the study include anhydrous cholestyramine, which helps bind certain substances in the intestines, and MRI contrast media to improve the clarity of brain scans.
Investigational drug: Tolebrutinib is administered orally as film-coated tablets. This medication is a kinase inhibitor that targets Bruton's tyrosine kinase, potentially reducing immune system activity that causes inflammation and nerve damage in multiple sclerosis. The study is currently in Phase 3, the final stage before potential approval for general use. The trial is expected to conclude by August 2029.
Summary
Both ongoing clinical trials for progressive relapsing multiple sclerosis are investigating the same medication, tolebrutinib, highlighting the concentrated research effort on this particular treatment approach. The trials are designed as long-term safety studies, with one running until August 2029 and monitoring participants for up to 36 months or longer.
Geographically, these trials have wide coverage across Europe. One study is being conducted in 24 countries across the continent, including Poland, Portugal, Finland, Estonia, Germany, and many others, while the second study is focused specifically on Denmark and the Netherlands. This broad geographic distribution allows researchers to gather diverse data from different populations.
Both trials require participants to have already completed previous Phase 2b or Phase 3 studies with tolebrutinib, meaning they are extension studies focused on understanding the long-term effects rather than initial safety testing. This approach ensures that all participants have prior experience with the medication and helps researchers track how the treatment performs over many years.
The focus on tolebrutinib reflects current scientific interest in medications that work by inhibiting Bruton's tyrosine kinase, which may offer a new approach to managing inflammation and nerve damage in multiple sclerosis. The inclusion of participants with various forms of the disease, including relapsing and progressive types, suggests that researchers are exploring whether this medication could benefit a wide range of patients.
