Ongoing Clinical Trials for Secondary Progressive Multiple Sclerosis
There are currently 7 clinical trials investigating new treatments and approaches for patients with secondary progressive multiple sclerosis. These studies are exploring various medications including tolebrutinib, cladribine, and experimental cell therapies, with trials taking place across multiple European countries. Researchers are focusing on slowing disease progression, managing symptoms, and understanding whether established treatments can be safely stopped in certain patient groups.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Croatia
- Czechia
- Denmark
- Espagne
- Estonia
- Finland
- France
- Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis
- Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis
- Study on Stopping Disease-Modifying Therapies in Inactive Secondary Progressive Multiple Sclerosis Patients Over 50 Using Glatiramer Acetate and Drug Combination
- 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 study is examining the long-term safety and tolerability of tolebrutinib, a medication being tested for different types of multiple sclerosis, including the secondary progressive form. The trial is designed for participants who have already completed a previous Phase 2b or Phase 3 tolebrutinib study.
Who can participate: Eligible participants must have relapsing multiple sclerosis, primary progressive multiple sclerosis, or non-relapsing secondary progressive multiple sclerosis. They should have completed one of the earlier tolebrutinib trials (Phase 2b LTS or one of four Phase 3 studies). Both men and women can take part, including those from vulnerable populations who may need extra care or protection.
Who cannot participate: The study excludes individuals with other serious health conditions that could interfere with the research, those currently enrolled in another clinical trial, people with recent infections requiring treatment, those who have had recent vaccinations, individuals with a history of certain cancers, pregnant or breastfeeding women, people with a history of drug or alcohol abuse, those who have had allergic reactions to similar medications, and anyone with conditions affecting their ability to understand or follow study instructions.
What the study involves: Participants receive tolebrutinib in the form of oral film-coated tablets or a placebo. Throughout the study, researchers monitor for any side effects and adverse events. The trial also tracks changes in the participants’ condition, such as disability progression or relapse rates, using regular assessments and MRI brain scans. The study is scheduled to continue until August 2029.
Investigational drug: Tolebrutinib works by inhibiting Bruton’s tyrosine kinase, a protein that plays a role in the immune response. This mechanism may help reduce inflammation and nerve damage in multiple sclerosis.
Study on Cladribine for Treating Secondary Progressive Multiple Sclerosis in Patients with Recent Progression and No Recent Relapses
This trial is investigating whether cladribine, administered through subcutaneous injections, can slow down the loss of brain volume in patients with secondary progressive multiple sclerosis who have experienced recent disease progression but no relapses in the past year.
Who can participate: Participants must provide written consent and have a diagnosis of secondary progressive multiple sclerosis. They should show evidence of disease worsening over the past 24 months, demonstrated by an increase in their Expanded Disability Status Scale score. Eligible participants must not have experienced any new attacks or relapses in the last 12 months and should have an EDSS score between 3.5 and 7.5. They must be between 30 and 65 years old and have had symptoms for at least 10 years. Women of childbearing age must agree to use effective contraception during the study and for six months afterward, and men must agree to similar precautions.
Who cannot participate: The study excludes patients who have had a relapse in the last 12 months, those who have not experienced progression in the last 24 months, and individuals who are part of vulnerable populations requiring special protection or care.
What the study involves: After initial assessment and randomization, participants receive either cladribine or placebo injections over a 26-week treatment period. Regular monitoring includes physical examinations, blood tests, and imaging studies to assess treatment safety and effectiveness. The study measures changes in disability, cognitive function, and quality of life, along with brain imaging and biomarker analysis. Long-term follow-up continues until the study’s estimated conclusion in June 2027.
Investigational drug: Cladribine is an immunosuppressive agent that targets and reduces certain immune cells, helping to slow brain volume loss associated with the progressive form of the condition.
Study on Long-Term Safety of Tolebrutinib for Patients with Relapsing or Progressive Multiple Sclerosis
This study focuses on the long-term safety and tolerability of tolebrutinib in individuals with various forms of multiple sclerosis, including the secondary progressive type. Like the first tolebrutinib study, it is designed for participants who have completed previous Phase 2b or Phase 3 trials.
Who can participate: Eligible participants must have relapsing multiple sclerosis, primary progressive multiple sclerosis, or non-relapsing secondary progressive multiple sclerosis. They should have completed specific earlier studies involving tolebrutinib. Both men and women from all populations, including vulnerable groups, are eligible.
Who cannot participate: The study excludes patients with certain nervous system diseases that may interfere with the research, individuals who don’t meet age requirements, those unable to follow study procedures or take medication as required, people with other medical conditions that might pose risks, pregnant or breastfeeding women, those currently in another clinical trial, individuals who have had recent major surgery or are planning surgery during the study, anyone with allergic reactions to the study medication or similar drugs, people with certain infections or diseases that could affect results, and individuals with a history of substance abuse or current illegal drug use.
What the study involves: Participants receive tolebrutinib as oral film-coated tablets according to the study protocol. Regular monitoring assesses long-term safety and tolerability, tracking adverse events, disability progression, and relapse rates. Brain imaging techniques measure changes in lesions over time. The study is expected to conclude by August 2029.
Investigational drug: Tolebrutinib is a kinase inhibitor that works by blocking Bruton’s tyrosine kinase, potentially reducing inflammation and nerve damage in the central nervous system.
Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis
This innovative trial is testing YTB323, a cell therapy approach that uses modified immune cells to target progressive multiple sclerosis. The study also involves preparatory medications including cyclophosphamide, tocilizumab, and fludarabine phosphate.
Who can participate: Participants must be between 18 and 60 years old and provide signed informed consent. They should be able to communicate well with the study team and understand the procedures involved, including lumbar puncture and brain MRI. Eligible participants must have a diagnosis of secondary progressive or primary progressive multiple sclerosis confirmed during screening, with disease duration less than 15 years. They must be able to walk and have an EDSS score between 3 and 6.5 at screening.
Who cannot participate: The study excludes patients with any other type of multiple sclerosis that is not non-active progressive multiple sclerosis, those outside the specified age range, and individuals from vulnerable populations who may need special protection.
What the study involves: After an initial visit with medical history review, physical examination, blood tests, and brain MRI, participants receive pre-treatment medications (cyclophosphamide and fludarabine phosphate) through intravenous infusion to prepare the body. The main treatment, YTB323, is then administered intravenously. Throughout the monitoring phase, participants have regular follow-up visits including blood draws, brain MRI scans, and other evaluations to track progress and safety. The study is expected to continue until June 2030.
Investigational drug: YTB323 is an immunotherapy that uses modified immune cells from the patient’s own body. It works by targeting specific cells in the immune system to help reduce damage to the nervous system.
Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis
This trial compares two medications, rituximab and ocrelizumab, both administered through intravenous infusion. The study aims to determine if rituximab is as effective as ocrelizumab in treating active forms of multiple sclerosis, including the secondary progressive type with signs of activity.
Who can participate: Eligible participants must be between 18 and 65 years old with a multiple sclerosis diagnosis according to 2017 McDonald criteria. They must have an EDSS score of 6.5 or less and meet specific criteria for active disease, which varies depending on treatment history and disease type. For those with progressive multiple sclerosis, activity can be demonstrated by recent relapses, contrast-enhancing lesions on MRI, new or enlarging T2 lesions, or elevated neurofilament light chain levels. All participants must sign written informed consent.
Who cannot participate: The study excludes patients without multiple sclerosis, those outside the specified age range, and individuals from vulnerable populations requiring special protection or care.
What the study involves: The study begins with administration of either ocrelizumab or rituximab through intravenous infusion. The core study period lasts 24 months, during which effectiveness is evaluated by monitoring for new or enlarging brain lesions. Regular assessments track disease progression and treatment side effects. An optional extension phase continues for an additional 36 months, examining long-term effects and the potential benefits of extended interval dosing for patients with stable disease. Throughout the study, regular monitoring assesses patient condition and treatment response.
Investigational drugs: Both ocrelizumab and rituximab are monoclonal antibodies that target CD20-positive B cells in the immune system. By depleting these cells, the medications aim to reduce the immune system’s attack on the nervous system.
Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients
This study investigates whether metformin, a medication commonly used for diabetes, can help slow progression in patients with non-active progressive multiple sclerosis. The trial compares metformin with placebo to assess effects on walking speed and other health measures over 96 weeks.
Who can participate: Participants must have a diagnosis of non-active progressive multiple sclerosis, meaning the disease is worsening without new attacks or brain lesions in the past 1-2 years. They should be between 18 and 70 years old with an EDSS score between 2.0 and 6.5. Participants must be able to provide informed consent and speak Dutch/Flemish or French, as study materials are available in these languages. They should have been using stable disease-modifying therapy or no treatment for at least the past year. Women of childbearing age must use adequate contraceptive measures during the study.
Who cannot participate: The study excludes patients with any other type of multiple sclerosis that is not non-active progressive multiple sclerosis, those outside the specified age range, and individuals from vulnerable populations unable to give informed consent.
What the study involves: After initial eligibility assessment, including medical history review and physical examination, participants are enrolled and undergo baseline measurements. These include tests for walking speed, hand function, cognitive function, and overall disability status, plus an MRI scan to evaluate brain volume. Participants are then randomly assigned to receive either metformin tablets or placebo, taken daily for 96 weeks. Regular follow-up visits throughout this period repeat baseline tests to track changes. A final assessment at the end of 96 weeks includes all previous tests to determine treatment effectiveness.
Investigational drug: Metformin is a biguanide that activates a protein in the body helping regulate energy use and cell growth. Researchers are exploring whether this mechanism can protect nerve cells from damage and slow disease progression.
Study on Stopping Disease-Modifying Therapies in Inactive Secondary Progressive Multiple Sclerosis Patients Over 50 Using Glatiramer Acetate and Drug Combination
This unique trial examines whether it is safe to stop disease-modifying therapies in older patients with inactive secondary progressive multiple sclerosis. The study compares outcomes between patients who stop treatment and those who continue, monitoring disease progression over two years.
Who can participate: Participants must be 50 years or older and have had secondary progressive multiple sclerosis for at least 3 years, with evidence of worsening (at least 1 point increase in EDSS score, or 0.5 points if the score is 5.5 or higher). They must have been on disease-modifying therapy for at least 3 years, which can include treatments like interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, or others (though not fingolimod or natalizumab in the year before joining). Importantly, there should be no evidence of active brain inflammation for at least 3 years, meaning no new symptoms or changes on MRI scans. Participants must have an EDSS score of 3 or higher.
Who cannot participate: The study excludes patients who have had a clinical relapse or radiological activity in the last 3 years, and those not classified as having inactive secondary progressive multiple sclerosis according to established criteria, meaning they must not have shown recent evidence of focal inflammatory activity for at least 3 years.
What the study involves: After initial assessment to confirm eligibility, including review of EDSS score and medical history, participants are assigned to either continue their current disease-modifying therapy or stop it. Throughout the trial, participants undergo regular clinical monitoring to assess health status and symptom changes, along with periodic MRI scans to check for new or enlarging brain lesions and brain volume changes. Disability progression is evaluated at regular intervals by checking for EDSS score increases or changes in physical abilities. Participants complete quality of life questionnaires measuring various aspects of daily living and well-being. A final comprehensive assessment at the end of the two-year period reviews all collected health data to determine the overall impact of continuing or withdrawing treatment.
Investigational approach: This study examines disease-modifying therapies as a class of treatments. These immunomodulatory agents work by modulating the immune system to reduce inflammation and prevent nervous system damage. The key question is whether these therapies remain beneficial in older patients with stable, inactive disease.
Summary
The seven ongoing clinical trials for secondary progressive multiple sclerosis reflect diverse research approaches. Multiple studies focus on tolebrutinib, a kinase inhibitor, with trials taking place across numerous European countries including Poland, Germany, France, Spain, Italy, and Scandinavia. This geographic distribution provides broad access to these investigational treatments.
The research landscape includes traditional pharmaceutical approaches, such as testing cladribine and metformin, alongside innovative cell therapy with YTB323. Notably, two studies address important practical questions: whether established medications like rituximab can match the effectiveness of newer treatments, and whether older patients with stable disease can safely discontinue therapy.
Most trials require participants to have specific disease characteristics, such as recent progression without relapses or absence of inflammatory activity. The studies employ comprehensive monitoring including regular MRI scans, disability assessments, and quality of life measures. Treatment durations range from two to several years, reflecting the chronic nature of the condition and the need for long-term safety data.
