Ongoing Clinical Trials for Relapsing-Remitting Multiple Sclerosis

There are currently 18 ongoing clinical trials investigating new treatments and therapeutic approaches for relapsing-remitting multiple sclerosis across multiple European countries. These studies are testing various medications including biological therapies, immunomodulatory drugs, stem cell transplantation, and innovative cell-based treatments, offering hope for improved disease management and quality of life for patients with this condition.

Clinical trial locations

Study Comparing ABP 692 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

This study compares two medications given through intravenous infusion: ABP 692 and Ocrevus. Both treatments are being tested to see which is more effective in managing the condition.

Who can participate: Eligible participants must have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the 2017 McDonald Criteria. They need to have a disability score between 0 and 5.5 on the Expanded Disability Status Scale, which measures how much the disease affects daily activities. Participants must also show recent disease activity and be neurologically stable, meaning they haven’t experienced a relapse for at least 28 days before joining the study. The study is open to adults aged 18 years and older.

Who cannot participate: People with other forms of multiple sclerosis besides relapsing-remitting cannot join. Those who fall outside the specified age range or belong to vulnerable populations requiring special care are also excluded. Additionally, individuals who don’t meet the health requirements set by the study organizers cannot participate.

Main goal: The study aims to compare how ABP 692 and Ocrevus work in the body and their effects on the disease. Researchers will monitor participants for 48 weeks, tracking the number of new active brain lesions using MRI scans. The treatments will be given every six months as intravenous infusions. The study will assess whether ABP 692 is as effective and safe as Ocrevus in treating relapsing-remitting multiple sclerosis.

Investigational drug: ABP 692 is a monoclonal antibody being tested as a potential biosimilar to Ocrevus. It works by targeting specific immune cells to reduce inflammation and prevent new brain lesions.

Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

This French study compares two treatments administered through intravenous infusion: Rituximab and Ocrelizumab. Both medications target specific immune cells called B-cells to help control the disease.

Who can participate: Participants must be between 18 and 55 years old with confirmed relapsing-remitting multiple sclerosis. They should have experienced disease activity in the past year, shown by at least one relapse or new brain lesions on MRI. Candidates must have an Expanded Disability Status Scale score of 5 or less and have had a brain MRI within six months before joining. Women of childbearing age must use effective birth control during the study and for 12 months afterward. All participants must have social insurance coverage and provide informed consent.

Who cannot participate: People without a multiple sclerosis diagnosis, those outside the specified age range, or individuals in vulnerable populations cannot participate. Those unwilling to follow study procedures, participating in other trials, or with recent infections are also excluded. Pregnant or breastfeeding women and those with allergies to the study medications cannot join.

Main goal: The two-year study aims to determine if Rituximab and Ocrelizumab are equally effective in achieving no evidence of disease activity. Researchers will monitor participants for relapses, disability progression, and quality of life. Regular MRI scans will track brain changes throughout the study period.

Investigational drugs: Rituximab and Ocrelizumab both work by targeting CD20-positive B cells, which are believed to contribute to the disease process in multiple sclerosis.

Study Comparing the Effects of Ozanimod and Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

This study focuses on children and adolescents with relapsing-remitting multiple sclerosis. It compares two oral medications: Ozanimod, tested at various doses, and Fingolimod. Both medications work by preventing certain immune cells from causing damage to the nervous system.

Who can participate: Participants must have been diagnosed with relapsing-remitting multiple sclerosis and weigh at least 30 kilograms. They should have experienced at least one relapse in the past year or two relapses in the past two years, or show evidence of new activity on brain MRI. Their disability score should be between 0 and 5.5, and they must be able to swallow capsules. Children who are sexually active must agree to use effective birth control.

Who cannot participate: Children with other forms of multiple sclerosis cannot join the study. Those who haven’t completed the initial 96 weeks of Part 1 or weren’t evaluated for safety and effectiveness in Part 1 are excluded.

Main goal: The core phase lasts 96 weeks, with an optional extension phase of additional monitoring. The study will track relapse rates, disability changes, and overall health through regular MRI scans and health assessments. Researchers aim to determine if Ozanimod is as effective as Fingolimod in reducing disease activity.

Investigational drugs: Ozanimod and Fingolimod are both sphingosine 1-phosphate receptor modulators that trap lymphocytes in lymph nodes, preventing them from reaching the brain and spinal cord where they could cause damage.

Study on the Effectiveness of Autologous Stem Cell Transplantation with Cytarabine in Patients with Aggressive Multiple Sclerosis

This Italian study investigates autologous hematopoietic stem cell transplantation, a procedure where patients receive their own stem cells to reset the immune system. The treatment aims to stop disease progression in aggressive forms of the condition.

Who can participate: Participants must have treatment-resistant relapsing-remitting multiple sclerosis diagnosed according to the 2017 McDonald criteria. They should be between 18 and 55 years old with a disability score between 2.0 and 6.0 on the Expanded Disability Status Scale. Disease must remain active despite at least six months of treatment, shown by at least one relapse or new MRI lesions. Candidates must be suitable for treatment with at least one disease-modifying therapy such as natalizumab, alemtuzumab, ocrelizumab, or ofatumumab.

Who cannot participate: People with other forms of multiple sclerosis, those outside the age range of 18-65 years, pregnant or breastfeeding women, and individuals in other clinical trials are excluded. Those with severe allergic reactions to study medications or serious health conditions that might interfere are also ineligible.

Main goal: The 36-month study aims to achieve no evidence of disease activity. The treatment involves collecting stem cells, followed by high-dose chemotherapy to eliminate diseased cells, then returning the stored stem cells to rebuild a healthy immune system. Regular monitoring includes MRI scans, physical assessments, and quality of life evaluations.

Investigational treatment: Autologous hematopoietic stem cell transplantation is a regenerative medicine approach designed to reset the immune system by replacing damaged cells with healthy ones.

Study on the Effects of IMU-838 (Vidofludimus Calcium) for Patients with Relapsing-Remitting Multiple Sclerosis

This study tests an oral medication called IMU-838 at different doses to evaluate its effectiveness in reducing disease activity as measured by MRI scans. The medication contains the active substance vidofludimus calcium.

Who can participate: Participants must be between 18 and 55 years old with a diagnosis of relapsing-remitting multiple sclerosis. They should have experienced at least two relapses in the last 24 months or one relapse in the last 12 months, plus at least one specific type of brain lesion on MRI in the past six months. Their disability score must be between 0 and 4.0. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 30 days afterward. Men must agree not to father a child during this period and use appropriate contraception.

Who cannot participate: People with other forms of multiple sclerosis, those outside the age range, and individuals unable to undergo MRI scans are excluded. Those with medical conditions interfering with the study, pregnant or breastfeeding women, and people taking certain interfering medications cannot participate. Individuals with drug or alcohol abuse history or severe allergies to similar medications are also excluded.

Main goal: The 24-week main treatment period, with an optional extended phase, aims to determine the effectiveness of a 45 mg daily dose of IMU-838 in treating relapsing-remitting multiple sclerosis. Participants undergo regular MRI scans to monitor disease activity and are assessed for any side effects.

Investigational drug: IMU-838 is an immunomodulatory agent administered orally that works by modulating immune responses, potentially through the inhibition of specific enzymes involved in the immune system.

Study of Lactobacillales and Lacidofil in Multiple Sclerosis Patients: Comparing Effectiveness of Probiotic Therapy

This Polish study evaluates the effectiveness of probiotics combined with standard treatments. Participants receive either Lacidofil or Trilac probiotics, while a control group receives no probiotics. All participants continue their regular treatment with either ofatumumab or ozanimod.

Who can participate: Participants must be between 18 and 45 years old with confirmed multiple sclerosis according to McDonald’s 2017 diagnostic criteria. They must have been receiving treatment with either ozanimod or ofatumumab for at least six months and haven’t received steroid treatment in the past three months. All participants must provide voluntary consent.

Who cannot participate: People below 18 or above 65 years, pregnant or breastfeeding women, and those with active infections are excluded. Individuals who used antibiotics within three months, have had gastrointestinal surgery, or have known allergies to probiotics cannot participate. Those in other clinical trials within 30 days, unable to follow procedures, or with severe disability are also excluded. People with uncontrolled medical conditions or history of substance abuse in the past year are ineligible.

Main goal: The 24-month study monitors disease activity through brain MRI scans at 12 and 24 months. Participants complete questionnaires assessing mental health, pain, fatigue, and quality of life. The study tracks the number of relapses and any side effects.

Investigational drugs: Trilac and Lacidofil are probiotic medications containing beneficial bacteria. They’re being studied for potential effects in reducing symptoms and disease activity through their influence on gut health and immune system function.

Study on Anti-CD20 Therapy and Drug Combination for Patients with Relapsing-Remitting Multiple Sclerosis

This French study compares continuing anti-CD20 therapy against switching to alternative treatments called platform therapies. Platform therapies include various medications such as Ofatumumab, Dimethyl Fumarate, and several others.

Who can participate: Participants must be 40 years or older with relapsing-remitting multiple sclerosis, having been treated with anti-CD20 therapy for at least three years without disease activity. For those on IV ocrelizumab or rituximab at extended intervals, the time between treatments shouldn’t exceed 12 months. A brain MRI must be performed according to specific protocol within six months before joining.

Who cannot participate: People without a multiple sclerosis diagnosis, those outside the specified age range, or individuals in vulnerable populations cannot participate.

Main goal: The three-year study aims to determine if switching to platform therapies is not worse than continuing anti-CD20 therapy in keeping the disease under control. Participants undergo regular follow-ups with clinical evaluations and MRI scans to monitor disease activity. The study tracks relapses, disability changes, infections, and measures certain blood substances.

Investigational drugs: Anti-CD20 therapy targets and reduces specific immune cells called B cells, while platform therapies work in different ways to reduce relapses and slow disease progression.

Study on Testosterone Undecanoate for Neuroprotection and Myelin Repair in Patients with Relapsing Remitting Multiple Sclerosis

This French study investigates whether testosterone treatment can help protect nerve cells and repair myelin, the protective covering of nerves. The treatment is given as NEBIDO through intramuscular injection every 12 weeks for 54 weeks.

Who can participate: Male participants must be between 18 and 55 years old with confirmed multiple sclerosis according to the revised McDonald criteria. They must have been receiving specific disease-modifying treatments for at least one year and have biological hypogonadism, meaning testosterone levels below 20 nmol/L. Those taking natalizumab must have negative JC virus status or a low index. Participants must have had no relapses in the past year and be neurologically stable for at least one month.

Who cannot participate: Non-male patients and those outside the specified age range or in vulnerable populations cannot participate.

Main goal: The study evaluates whether testosterone treatment can reduce brain tissue loss and improve nerve function over 54 weeks. Participants continue their existing disease-modifying therapy while receiving testosterone treatment. Regular assessments include MRI scans, cognitive function tests, quality of life questionnaires, and safety monitoring.

Investigational drug: Testosterone undecanoate (NEBIDO) is being studied for its potential neuroprotective and myelin repair effects. Participants also continue their standard disease-modifying therapies including natalizumab, fingolimod, ponesimod, ocrelizumab, or ofatumumab.

Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis

This Danish study compares Rituximab, used as a biosimilar, with Ocrelizumab in treating active forms of the condition. Both medications are given through intravenous infusion directly into the bloodstream.

Who can participate: Participants must be between 18 and 65 years old with a multiple sclerosis diagnosis according to the 2017 McDonald criteria. Their disability score should be 6.5 or less on the Expanded Disability Status Scale. For untreated patients or those without recent treatment, specific criteria include having at least two relapses in the past year or one relapse plus specific brain lesions. For previously treated patients, different criteria apply based on relapse history and MRI findings.

Who cannot participate: People without multiple sclerosis, those outside the age range, or individuals in vulnerable populations cannot participate.

Main goal: The study runs for 24 months with an optional 36-month extension phase. It focuses on whether patients remain free of new or enlarging brain lesions. The extension phase examines long-term effects and whether extending time between doses might be beneficial for stable patients. Regular monitoring includes MRI scans and health assessments.

Investigational drugs: Both Rituximab and Ocrelizumab target CD20-positive B cells to reduce the immune system’s attack on the nervous system. They are monoclonal antibodies given through intravenous infusion.

Study comparing stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab in patients with aggressive relapsing-remitting multiple sclerosis

This multi-country Nordic study compares autologous hematopoietic stem cell transplantation with three alternative medications: alemtuzumab, cladribine, or ocrelizumab. Participants are randomly assigned to one of these treatment options and monitored for five years.

Who can participate: Participants must be between 18 and 50 years old with confirmed relapsing-remitting multiple sclerosis according to McDonald criteria. Their disability score should be between 0 and 5.5. The disease must remain active despite current treatment, shown by at least one relapse and active lesions on MRI. Disease activity must have occurred at least three months after starting current treatment. Both men and women who can become pregnant must use highly effective birth control throughout the study.

Who cannot participate: People below 18 or above 50 years, pregnant or breastfeeding women, and those with active infections are excluded. Individuals with significant heart, liver, or kidney problems, cancer history within five years, or severe mental health conditions cannot participate. Those with allergies to study medications, previous stem cell transplantation, or uncontrolled medical conditions are also excluded.

Main goal: The five-year study evaluates which treatment is more effective and safe for aggressive forms of the disease. Regular assessments include brain scans, physical ability tests, cognitive function evaluations, and quality of life questionnaires.

Investigational treatments: The study compares stem cell transplantation (HSCT), which aims to reset the immune system, with alemtuzumab, cladribine, and ocrelizumab, which work through different immune system mechanisms.

Summary

The current research landscape for relapsing-remitting multiple sclerosis shows significant international collaboration, with trials conducted across numerous European countries. France leads with participation in eight trials, followed by Poland with nine trials and Italy with nine trials. Several Western and Northern European countries are also actively involved in this research.

A notable trend is the focus on anti-CD20 therapies, particularly ocrelizumab, which appears in multiple trials either as the primary investigational drug or as a comparator. Several studies are investigating biosimilars and alternative formulations of established treatments, potentially offering more treatment options for patients. There is also growing interest in innovative approaches, including stem cell transplantation, probiotic therapy, and cell-based treatments.

Many trials specifically address pediatric populations, reflecting the recognition that children and adolescents with the condition require dedicated research. Studies comparing different doses of established medications and evaluating treatment de-escalation strategies demonstrate efforts to optimize therapy while minimizing potential side effects.

The research encompasses various administration routes, including intravenous infusions, oral medications, and subcutaneous injections, providing flexibility in treatment delivery. Most studies emphasize safety alongside efficacy, with comprehensive monitoring protocols including regular MRI scans, disability assessments, and quality of life evaluations.

#1 Clinical Trials Search in Europe

Relapsing-remitting multiple sclerosis – Trials in Disease

Ongoing Clinical Trials for Relapsing-Remitting Multiple Sclerosis

Clinical trial locations

Study Comparing ABP 692 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

Study Comparing the Effects of Ozanimod and Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

Study on the Effectiveness of Autologous Stem Cell Transplantation with Cytarabine in Patients with Aggressive Multiple Sclerosis

Study on the Effects of IMU-838 (Vidofludimus Calcium) for Patients with Relapsing-Remitting Multiple Sclerosis

Study of Lactobacillales and Lacidofil in Multiple Sclerosis Patients: Comparing Effectiveness of Probiotic Therapy

Study on Anti-CD20 Therapy and Drug Combination for Patients with Relapsing-Remitting Multiple Sclerosis

Study on Testosterone Undecanoate for Neuroprotection and Myelin Repair in Patients with Relapsing Remitting Multiple Sclerosis

Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis

Study comparing stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab in patients with aggressive relapsing-remitting multiple sclerosis

Summary

Ongoing Clinical Trials on Relapsing-remitting multiple sclerosis

Study on the Effectiveness of Autologous Stem Cell Transplantation with Cytarabine in Patients with Aggressive Multiple Sclerosis

Study Comparing the Effects of Ozanimod and Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

Study on the Effects of IMU-838 (Vidofludimus Calcium) for Patients with Relapsing-Remitting Multiple Sclerosis

Study on Testosterone Undecanoate for Neuroprotection and Myelin Repair in Patients with Relapsing Remitting Multiple Sclerosis

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

Study of Lactobacillales and Lacidofil in Multiple Sclerosis Patients: Comparing Effectiveness of Probiotic Therapy

Study on Anti-CD20 Therapy and Drug Combination for Patients with Relapsing-Remitting Multiple Sclerosis

Study Comparing ABP 692 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis

Study on the Safety and Efficacy of CLS12311 and Autologous Red Blood Cells for Patients with Relapsing Remitting Multiple Sclerosis

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Relapsing-remitting multiple sclerosis – Trials in Disease

Ongoing Clinical Trials for Relapsing-Remitting Multiple Sclerosis

Clinical trial locations

Summary

Ongoing Clinical Trials on Relapsing-remitting multiple sclerosis

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