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Ongoing Clinical Trials for Relapsing Multiple Sclerosis

There are currently 18 ongoing clinical trials investigating new treatments for relapsing multiple sclerosis, a chronic condition where the immune system attacks the protective covering of nerves. These studies are testing various medications including remibrutinib, ublituximab, tolebrutinib, fenebrutinib, ozanimod, and other novel therapies across multiple European countries.

Clinical trial locations

Study comparing remibrutinib and ocrelizumab in patients with relapsing multiple sclerosis who switch from ocrelizumab treatment

This trial is comparing two treatments for people currently taking ocrelizumab. Participants must be 40 years or older with a confirmed diagnosis according to the 2017 McDonald criteria. The study is designed for patients who have been neurologically stable for at least 30 days before screening, meaning no relapses or significant symptom changes during this period.

Inclusion criteria require participants to be on standard doses of ocrelizumab as part of their regular care and considered suitable by their doctor to switch to remibrutinib. Both men and women can participate in the study.

Exclusion criteria include having other neurological conditions besides multiple sclerosis, being pregnant or breastfeeding, having severe allergic reactions to similar medications, active serious infections like hepatitis B or tuberculosis, significant heart problems or uncontrolled high blood pressure, cancer history within the past 5 years, severe liver or kidney problems, recent live vaccinations within 6 weeks, current participation in other trials, inability to undergo MRI scans, recent drug or alcohol abuse, mental health conditions that could interfere with study procedures, medications that could interact with the study drug, and blood disorders.

Main focus: The study aims to determine if remibrutinib is as effective as ocrelizumab in controlling disease activity as seen on MRI scans. Participants will be followed for 24 months to compare how well both treatments work, with the option to continue receiving remibrutinib in an extended period.

Investigational drugs: Remibrutinib is a new oral medication that works by blocking Bruton’s tyrosine kinase, a protein involved in inflammation. Ocrelizumab is an established treatment given by infusion or injection that reduces specific B cells thought to contribute to nerve damage.

Study comparing subcutaneous versus intravenous ublituximab in patients with relapsing multiple sclerosis

This trial compares two different ways of administering ublituximab: under the skin versus directly into a vein. Participants must be between 18 and 65 years old with a confirmed diagnosis of relapsing multiple sclerosis. An EDSS score of 5.5 or lower is required, which measures disability level in multiple sclerosis patients.

Inclusion criteria require participants to meet these age and diagnostic requirements. Women who can become pregnant must agree to use highly effective birth control during the study and for a period after the last dose.

Exclusion criteria include severe allergic reactions or anaphylaxis, active or chronic infections, current cancer diagnosis or cancer history in the past 5 years (except treated skin cancer), severe liver or kidney disease, uncontrolled high blood pressure, heart problems, pregnancy or breastfeeding, use of other medications for multiple sclerosis within the past 6 months, participation in other trials within the past 30 days, drug or alcohol abuse in the past year, mental health conditions interfering with study participation, and inability to comply with study procedures.

Main focus: The study examines how the body processes ublituximab when given through different methods and evaluates its effects on disease symptoms. The research team will monitor participants’ responses to treatment, including effectiveness and any side effects that may occur.

Investigational drugs: Ublituximab (intravenous form) targets specific immune system cells and is administered through a vein. Ublituximab (subcutaneous form) is the same medication but given as an injection under the skin, being tested for effectiveness and convenience compared to the intravenous version.

Study of LY3541860 and Meglumine Gadoterate for Adults with Relapsing Multiple Sclerosis

This trial evaluates a new treatment called LY3541860 compared to a placebo. Participants must have relapsing forms of multiple sclerosis according to 2017 guidelines. They must have experienced at least one documented relapse within the past year, two documented relapses within the past two years, or at least one active brain lesion in the past 180 days before the study starts.

Inclusion criteria require an EDSS score of 5.5 or less at screening and when randomly assigned to a group. Both men and women can participate, and the study does not include vulnerable populations.

Exclusion criteria include not having relapsing multiple sclerosis, not being within the specified age range, being part of a vulnerable population, and not meeting other specific health criteria set by the study.

Main focus: The study aims to see if LY3541860 can slow down the formation of new brain lesions in people with this type of multiple sclerosis. These lesions are detected using MRI scans, and the study will monitor participants to observe any changes in the number of new brain lesions from the start to the end.

Investigational drugs: LY3541860 is a medication being studied for its potential to slow down the formation of new brain lesions. The trial assesses how effective this medication is in reducing the number of new lesions that appear on MRI scans of the brain.

Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis

This long-term safety study focuses on tolebrutinib in people with different types of multiple sclerosis, including relapsing, primary progressive, and nonrelapsing secondary progressive forms. Participants must have completed a previous Phase 2b or Phase 3 trial involving tolebrutinib, including those who temporarily discontinued due to a national emergency but completed trial visits.

Inclusion criteria require completion of a specific earlier study. Both men and women are eligible, and the study includes people from vulnerable populations.

Exclusion criteria include certain nervous system diseases, not meeting age requirements, inability to follow study procedures or take medication as required, other medical conditions that might interfere with the study or pose health risks, pregnancy or breastfeeding, current participation in another trial, recent major surgery or planned surgery during the study, history of allergic reactions to the study medication, certain infections or diseases that could affect study results, and history of substance abuse or current illegal drug use.

Main focus: The study aims to understand how safe and tolerable tolebrutinib is over a long period. The study will monitor participants for any side effects or adverse events while taking the medication, track changes in condition such as disability progression or relapse rates, and assess any side effects experienced during the treatment.

Investigational drugs: Tolebrutinib is a medication being studied for its long-term safety and tolerability. The goal is to see how well patients can tolerate the medication over an extended period and to monitor any potential side effects.

Study on the Effectiveness and Safety of Remibrutinib Compared to Teriflunomide for Patients with Relapsing Multiple Sclerosis

This study compares remibrutinib with teriflunomide to determine if remibrutinib is more effective in reducing the frequency of relapses. Participants must be between 18 and 55 years old and have a diagnosis according to the 2017 McDonald criteria. They must have experienced at least one documented relapse in the past year, two documented relapses in the past two years, or one active Gadolinium-enhancing lesion in the past year.

Inclusion criteria require patients to provide signed informed consent before any assessments, have an EDSS score between 0 and 5.5, and be neurologically stable for at least one month before screening and randomization, meaning no new or worsening symptoms during this time.

Exclusion criteria include having a different condition than multiple sclerosis, not being within the specified age range, not being part of the specified clinical trial group, not being male or female, and being considered part of a vulnerable population.

Main focus: The study determines if remibrutinib is more effective than teriflunomide in reducing the frequency of relapses. Participants will be randomly assigned to receive either remibrutinib, teriflunomide, or a placebo, followed by an extended treatment phase where all participants will receive remibrutinib.

Investigational drugs: Remibrutinib is a medication being studied for its potential to reduce the frequency of relapses, working by inhibiting Bruton’s tyrosine kinase, which plays a role in immune response. Teriflunomide is a medication currently used to treat relapsing multiple sclerosis, working by reducing inflammation and slowing down the immune system’s attack on the nervous system.

Study on the Effectiveness and Safety of Remibrutinib Compared to Teriflunomide for Patients with Relapsing Multiple Sclerosis

This trial compares remibrutinib with teriflunomide to determine effectiveness and safety. Participants must be between 18 and 55 years old with a diagnosis according to the 2017 McDonald criteria. They must have had at least one documented relapse in the past year, two documented relapses in the past 2 years, or one active Gadolinium-enhancing lesion in the past 12 months.

Inclusion criteria require providing signed informed consent before any study-related assessments, having an EDSS score between 0 and 5.5 at screening and randomization, and being neurologically stable for at least 1 month before screening and randomization, meaning no MS relapses during this time.

Exclusion criteria include having a different condition than multiple sclerosis, not being within the specified age range, not being part of the specified clinical trial group, being considered part of a vulnerable population, and not meeting other specific criteria set by the study.

Main focus: The study aims to determine if remibrutinib is better than teriflunomide in reducing the number of relapses. Participants will receive either remibrutinib or teriflunomide, and some may receive a placebo. All participants will have the opportunity to receive remibrutinib for an extended period after the initial phase.

Investigational drugs: Remibrutinib is being studied for its potential to reduce the frequency of relapses, working by inhibiting Bruton’s tyrosine kinase. Teriflunomide is currently used to treat relapsing multiple sclerosis, working by inhibiting an enzyme involved in the proliferation of activated lymphocytes, thereby modulating the immune response.

Study on the Effects of Ozanimod on Inflammation in Patients with Relapsing Multiple Sclerosis

This trial studies how ozanimod affects inflammation in the brain, particularly in the meninges, which are protective layers around the brain and spinal cord. Participants must be between 18 and 65 years old with a diagnosis of relapsing-remitting multiple sclerosis according to 2017 McDonald criteria. Treatment with ozanimod must have started within 30 to 90 days before enrollment, following a specific dose escalation regimen.

Inclusion criteria require at least one of the following in the past year before starting therapy: at least one relapse or at least one gadolinium-enhancing lesion or a new T2/FLAIR lesion on MRI. An EDSS score between 0 and 5 at the time of starting ozanimod is required. At least 2 mL of cerebrospinal fluid and 10 mL of blood collected before starting ozanimod and stored at -80°C are needed. An MRI scan done at least 90 days before starting ozanimod is required. Participants must be positive for varicella zoster virus immunoglobulin G antibody or received vaccination at least 28 days before starting ozanimod. A negative pregnancy test and use of highly effective contraception methods are required.

Exclusion criteria include having a different type of multiple sclerosis, not being within the specified age range, not being part of the specific group being studied, not being male or female, and being considered part of a vulnerable population.

Main focus: The study aims to understand how ozanimod affects inflammation in the brain, particularly in the meninges. It will also look at how the medication impacts glial cells, which support and protect nerve cells. Participants will take ozanimod for one year, and researchers will monitor changes in specific proteins and markers in cerebrospinal fluid and blood.

Investigational drugs: Ozanimod is a medication being studied for its effects on inflammation. It is believed to help reduce inflammation in the brain and spinal cord, which may help manage symptoms and slow disease progression.

Study on the Safety and Efficacy of BIIB091 and Diroximel Fumarate for Patients with Relapsing Multiple Sclerosis

This trial tests BIIB091, both on its own and in combination with Diroximel Fumarate. Participants must have a diagnosis of relapsing forms of multiple sclerosis, including relapsing-remitting or active secondary progressive, according to 2017 Revised McDonald criteria. Time since onset of symptoms must be less than 20 years.

Inclusion criteria require an EDSS score between 0 and 5.0 at the start of the study and having experienced at least 2 clinical relapses in the last 24 months (but not within 30 days before study starts), at least 1 clinical relapse in the past 24 months plus at least 1 new brain MRI lesion in the past 12 months, or at least 1 Gadolinium-enhancing lesion on a brain MRI within 6 months before study starts. Both males and females can participate.

Exclusion criteria include any other serious health conditions that might interfere with the study, pregnancy or breastfeeding, recent infections requiring treatment, severe allergic reactions to study medication, use of other investigational drugs within a certain period before the study, drug or alcohol abuse, significant liver or kidney problems, history of cancer (except certain skin cancers), uncontrolled high blood pressure or heart disease, and recent vaccination.

Main focus: The trial is divided into two parts. In the first part, participants will receive BIIB091 by itself to assess its safety and tolerability. In the second part, participants will receive a combination of BIIB091 and Diroximel Fumarate, or Diroximel Fumarate alone, to compare effects on brain inflammation as seen on MRI scans.

Investigational drugs: BIIB091 is being studied for its potential to help reduce inflammation in the central nervous system, a key problem in multiple sclerosis. Diroximel Fumarate is already used to treat relapsing forms of multiple sclerosis, working by helping to reduce inflammation and protect nerves from damage.

Study on Ublituximab and Drug Combination for Patients with Myasthenia Gravis or Relapsing Multiple Sclerosis

This trial studies ublituximab in patients with myasthenia gravis and relapsing multiple sclerosis. For patients with relapsing multiple sclerosis, participants must be between 18 and 65 years old with a diagnosis according to 2017 Revised McDonald criteria. They must have an EDSS score of 5.5 or less at screening and be neurologically stable before receiving the first dose of ublituximab.

Inclusion criteria for relapsing multiple sclerosis patients require age between 18 and 65 years, diagnosis according to specific criteria, EDSS score of 5.5 or less, neurological stability, and for female participants who can have children, agreement to use effective birth control from the time of consent, throughout the study, and for 6 months after the last dose. IgG and absolute lymphocyte count must be at required levels during screening.

Exclusion criteria include history of severe allergic reactions to similar medications, current pregnancy or breastfeeding, active infections requiring treatment, history of cancer within the last five years (except certain skin cancers), significant heart problems, uncontrolled high blood pressure, liver or kidney disease not well managed, receiving another investigational drug within the last 30 days, history of drug or alcohol abuse within the last year, and inability to comply with study procedures.

Main focus: The purpose is to understand how the body processes and responds to ublituximab when given either through a vein or under the skin. The study will monitor effects on B-cells, which are specific immune cells, and gather information about the safety and effectiveness of ublituximab in treating these autoimmune conditions.

Investigational drugs: Ublituximab is a monoclonal antibody designed to target specific cells in the immune system. The study aims to understand how the body processes this medication and how it affects the immune system in patients with autoimmune conditions.

Study on Fenebrutinib for Children and Teens with Relapsing Multiple Sclerosis

This trial tests fenebrutinib in children and teenagers between 10 and 17 years old. Participants must have a diagnosis according to specific medical guidelines for children and teenagers and an EDSS score between 0 and 5.5. They must be up to date on all vaccinations as recommended by local or national health guidelines.

Inclusion criteria require being 10 to 17 years old at the time of signing the consent form, having a confirmed diagnosis according to specific guidelines, having an EDSS score between 0 and 5.5, being up to date on vaccinations, and agreeing to either not have sexual intercourse or consistently use effective birth control methods.

Exclusion criteria include not having a diagnosis of relapsing multiple sclerosis, being under 2 years old, and not being part of the specified vulnerable population.

Main focus: The study aims to understand how fenebrutinib is processed in the body, how effective it is in preventing symptoms, and how safe it is for young patients. The study will monitor the number of new brain lesions using MRI scans and track any side effects and changes in health indicators.

Investigational drugs: Fenebrutinib is a medication being studied for its effects on children and adolescents with relapsing multiple sclerosis. It is designed to help manage the disease by targeting specific pathways in the immune system, potentially reducing the frequency and severity of relapses.

Study on Long-Term Safety of Tolebrutinib for Patients with Relapsing or Progressive Multiple Sclerosis

This long-term safety study of tolebrutinib includes participants with relapsing, primary progressive, and non-relapsing secondary progressive multiple sclerosis. Participants must have completed a previous Phase 2b or Phase 3 trial involving tolebrutinib, including those who temporarily discontinued due to a national emergency but completed trial visits.

Inclusion criteria require completion of specific earlier studies. Both men and women are eligible, and the study includes people from vulnerable populations.

Exclusion criteria include certain nervous system diseases, not meeting age requirements, inability to follow study procedures or take medication as required, other medical conditions that might interfere with the study or pose health risks, pregnancy or breastfeeding, current participation in another trial, recent major surgery or planned surgery, history of allergic reactions to study medication, certain infections or diseases that could affect study results, and history of substance abuse or current illegal drug use.

Main focus: The study aims to determine how safe and tolerable tolebrutinib is over a long period. Participants will take the medication orally, and the study will last for up to 36 months, monitoring participants for any adverse events and tracking disability progression and changes in the brain using MRI scans.

Investigational drugs: Tolebrutinib is being studied for its long-term safety and tolerability. The goal is to see how well patients can tolerate the medication over an extended period and to monitor any potential side effects.

Summary

The 18 ongoing clinical trials for relapsing multiple sclerosis reflect a diverse research landscape across Europe. A notable concentration of trials is taking place in Poland, which hosts 10 or more studies, followed by countries such as Germany, Spain, Italy, and France. This geographic distribution suggests strong research infrastructure and patient recruitment capabilities in these regions.

Several patterns emerge from these trials. BTK inhibitors represent a significant focus, with multiple studies investigating remibrutinib, fenebrutinib, and tolebrutinib. These oral medications offer potential advantages in convenience compared to traditional injectable therapies. Remibrutinib is being compared directly to teriflunomide in multiple Phase 3 trials, while also being studied as a switch option for patients currently on ocrelizumab.

Monoclonal antibodies continue to be investigated, with ublituximab being tested in various administration routes (subcutaneous versus intravenous) and in different patient populations. Long-term safety studies for tolebrutinib span multiple years and countries, reflecting the importance of understanding extended treatment effects.

Several trials include pediatric populations, notably the fenebrutinib study for children and teens aged 10-18 years, addressing the critical need for age-appropriate treatment options. Other innovative approaches include YTB323, a cell therapy being tested in patients who have active disease despite highly effective therapy, and ozanimod studies examining its effects on meningeal inflammation.

Most trials require participants to have experienced recent disease activity, typically measured by clinical relapses or MRI lesions within the past 12-24 months, and maintain EDSS scores generally between 0 and 5.5. Common exclusion criteria across studies include pregnancy, active infections, severe organ dysfunction, and recent use of other disease-modifying therapies.

Ongoing Clinical Trials on Relapsing multiple sclerosis

  • A study to evaluate the safety and how the body uses ublituximab injections in patients with multiple sclerosis

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study of ublituximab compared to fingolimod for children and teenagers aged 10 to 17 years with relapsing multiple sclerosis

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Poland Slovakia

  • Study on the Effectiveness of Ublituximab and Drug Combination for Patients with Relapsing Multiple Sclerosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +17

  • Study on Long-Term Safety of Tolebrutinib for Patients with Relapsing or Progressive Multiple Sclerosis

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark The Netherlands

  • Study on the Effectiveness of Vidofludimus Calcium (IMU-838) in Adults with Relapsing Multiple Sclerosis

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Germany Lithuania Poland

  • Study on the Effectiveness and Safety of Remibrutinib Compared to Teriflunomide for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia Estonia France Germany +9

  • Study comparing subcutaneous versus intravenous ublituximab in patients with relapsing multiple sclerosis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia Hungary

  • Study on Fenebrutinib for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    2 1
    Investigated diseases:
    Croatia Czechia Slovakia

  • Study on the Effects of Vidofludimus Calcium in Adults with Relapsing Multiple Sclerosis

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Estonia Germany Poland Romania

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