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Ongoing Clinical Trials for Multiple Sclerosis Relapse

There are currently 6 clinical trials investigating treatments for multiple sclerosis relapse across Europe. These studies are exploring medications such as ofatumumab and ocrelizumab to help manage relapses, slow disease progression, and improve long-term outcomes for people living with relapsing forms of this condition.

Clinical trial locations

Study on Ofatumumab Levels in Breast Milk of Women with Relapsing Multiple Sclerosis

This study focuses on breastfeeding women who have recently given birth and are managing relapsing forms of the condition. The trial aims to measure how much of the medication ofatumumab passes into breast milk and whether it affects breastfed infants.

Who can participate: Women with relapsing forms of the condition who are at least 18 years old, have recently given birth to a full-term baby (at least 37 weeks), and plan to exclusively breastfeed. Participants must be planning to start or restart ofatumumab treatment between 2 to 24 weeks after delivery. This decision should be made independently with their doctor, not because of the study.

Who cannot participate: Women with other serious health conditions that could interfere with the study, those taking medications that might affect results, anyone with allergies to the study medication, those with a history of substance abuse, women who are pregnant or planning to become pregnant, recent participants in other trials, those with active infections, immune system conditions, certain mental health conditions, or a history of cancer (except certain successfully treated types).

What the study involves: Participants receive ofatumumab injections (20 mg under the skin) as part of their regular treatment. They provide breast milk samples before their second maintenance dose and then at 7, 14, 21, and 28 days afterward. Both mothers and infants are monitored for any health changes for up to 12 months after treatment begins.

Study medication: Ofatumumab (brand name Kesimpta) is a monoclonal antibody that targets specific immune cells to help reduce relapses. It is given as an injection under the skin.

Study on Long-Term Safety and Effectiveness of Ofatumumab for Patients with Relapsing Multiple Sclerosis

This trial evaluates the long-term safety and effectiveness of ofatumumab in people with the relapsing form of the condition. The study follows participants for up to 240 weeks (approximately 4.5 years) to gather comprehensive data on how well the medication is tolerated and how it affects disease progression over time.

Who can participate: Adults (18 years or older when they joined the previous study) who have relapsing forms of the condition and who previously participated in a Novartis study involving ofatumumab at a dose of 20 mg under the skin every 4 weeks. Participants must have completed that previous study while still taking the medication and must provide written informed consent. Both males and females are eligible.

Who cannot participate: People with other serious health conditions that could interfere, those who are pregnant or breastfeeding, anyone with recent infections requiring antibiotics, those who received other treatments for the condition within the last month, people with a history of allergic reactions to similar medications, recent participants in other trials, those with substance abuse history, anyone with immune system conditions, those diagnosed with cancer in the past five years, or people unable to understand or follow study instructions.

What the study involves: Participants receive ofatumumab injections (20 mg under the skin) once every four weeks. Regular monitoring occurs throughout the study period to assess safety, tolerability, and effectiveness. Researchers track relapse rates, disability progression, side effects, and any changes in laboratory or vital sign results.

Study medication: Ofatumumab is a monoclonal antibody that targets and depletes B cells, which are involved in the abnormal immune response. It is administered as a subcutaneous injection every four weeks.

Study on Ofatumumab for Patients with Relapsing Multiple Sclerosis Transitioning from Fumarate-Based Therapies or Fingolimod

This study examines how well ofatumumab works for people whose condition has worsened despite being treated with fumarate-based therapies or fingolimod. The trial runs for 96 weeks and focuses on patients who have experienced breakthrough disease activity while on their previous medications.

Who can participate: Adults diagnosed with relapsing forms of the condition according to 2017 criteria, with a disability score between 0 and 4 on the Expanded Disability Status Scale. Participants must have used no more than three different disease-modifying therapies (with all fumarate types counted as one) and must be switching from fumarate-based treatments or fingolimod after using them for at least six months. They must have experienced breakthrough disease activity (at least one relapse or new/growing lesions on MRI scans) while properly using their previous medication. Participants must be neurologically stable for at least one month before starting the study medication.

Who cannot participate: People without a diagnosis of the relapsing form, those who have not experienced breakthrough disease on fumarates or fingolimod, anyone outside the specified age range, those unwilling or unable to follow study procedures, people with other medical conditions that might interfere, pregnant or breastfeeding women, current participants in other trials, and those with certain infections or diseases that could affect the study.

What the study involves: Participants receive ofatumumab injections (20 mg under the skin) every four weeks for 96 weeks. Researchers monitor the annual relapse rate based on confirmed relapses, track any side effects including injection reactions, and monitor changes in laboratory results and vital signs. The study also evaluates patient-reported outcomes and treatment discontinuation due to lack of effectiveness or safety concerns.

Study medications: Ofatumumab targets specific immune cells involved in the disease process. Fumarate-based therapies and fingolimod are medications previously used by participants to manage their condition by reducing inflammation and relapse frequency.

Study on the Effectiveness and Safety of Ocrelizumab, Methylprednisolone, and Diphenhydramine Hydrochloride in Patients with Multiple Sclerosis

This trial investigates the long-term effectiveness and safety of ocrelizumab in patients who previously participated in a related clinical trial. The study uses MRI scans to observe changes in the brain and monitors disease activity, disability levels, and relapse occurrence over time.

Who can participate: Patients who can follow study rules and who are eligible to continue into the LIBERTO study based on previous participation in a Roche-sponsored trial. This includes women who were pregnant during earlier studies and are still being monitored for safety, with continuation based on the study doctor’s assessment of risks and benefits. Participants must meet criteria to receive more treatment with ocrelizumab. Women of childbearing potential must agree to use acceptable birth control during treatment and for at least 6 months after the last dose.

Who cannot participate: People who have not been previously enrolled in a Roche-sponsored phase IIIb/IV trial, those with other significant health conditions that might interfere, pregnant or breastfeeding women, anyone unable to follow procedures or attend visits, people with severe allergic reactions to medications, current participants in other trials, those with substance abuse history, anyone who received live vaccines within 4 weeks, people with active infections requiring treatment, those with immune system conditions, people with certain mental health conditions, or anyone with a history of cancer (except certain types of skin cancer).

What the study involves: Participants undergo initial assessments including medical history review and baseline tests. They receive methylprednisolone (500 mg intravenously) to prepare for the main treatment, followed by diphenhydramine hydrochloride (50 mg orally) to manage potential allergic reactions. The main treatment is ocrelizumab (300 mg infusion through a vein), with paracetamol (1000 mg orally) available for fever or discomfort. Regular follow-up visits monitor progress, and ongoing assessments track changes in symptoms, disability progression, relapse rates, and quality of life.

Study medication: Ocrelizumab is a monoclonal antibody that targets and reduces certain immune cells believed to play a role in nerve damage. It is given as an intravenous infusion to slow disease progression and reduce relapse frequency.

Study on the Effectiveness and Tolerability of Ofatumumab Compared to a Drug Combination for Patients with Newly Diagnosed Relapsing Multiple Sclerosis

This study compares ofatumumab given as a monthly injection against other first-line treatments for people recently diagnosed with the relapsing form who have not yet received treatment. The trial lasts approximately 15 months and evaluates which treatment is more effective in preventing relapses and slowing disease progression.

Who can participate: Adults between 18 and 55 years old with a diagnosis of the relapsing form according to 2017 criteria. Participants must not have received any previous treatment, and it should be 5 years or less since their first symptom appeared. They must have a disability score between 0 and 4.0 on the Expanded Disability Status Scale and be neurologically stable for at least one month before starting treatment. Participants must have had at least one relapse or one active lesion on an MRI scan in the year before screening and be able to undergo MRI assessments. They must be suitable for treatment with first-line self-administered therapies or ofatumumab.

Who cannot participate: People who have been previously treated for the relapsing form, those not newly diagnosed, anyone not treatment-naïve (meaning they have already started treatment), people outside the specified age range, or those who are part of a vulnerable population requiring special protection.

What the study involves: Participants are randomly assigned to receive either ofatumumab (20 mg subcutaneous injection once a month) or one of several first-line treatments (including glatiramer acetate, interferons, teriflunomide, dimethyl fumarate, diroximel fumarate, or peginterferon beta-1a). Some participants receive a placebo for comparison. Throughout 15 months, researchers monitor the absence of relapses and new MRI activity, evaluate changes in disability status, and track the presence of new or enlarged brain lesions. Key assessments occur at months 3, 9, and 15.

Study medications: Ofatumumab targets and depletes B-cells involved in the immune response. First-line disease-modifying therapies are standard treatments that help manage the disease and reduce symptoms, with administration methods varying by medication.

Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Relapsing Multiple Sclerosis

This trial investigates whether a higher dose of ocrelizumab is more effective than the currently approved dose in reducing disability progression. Participants are monitored to assess the impact on their condition, with researchers tracking brain volume changes, protein levels in the blood, and specific immune cell counts.

Who can participate: Adults between 18 and 55 years old with a diagnosis of the relapsing form (including relapsing-remitting or active secondary progressive forms) according to revised 2017 McDonald Criteria. Participants must have had at least two documented relapses in the last 2 years or one relapse in the past year, with no relapse within 30 days before screening and study start. They must be neurologically stable for at least 30 days before baseline assessments, have a disability score between 0 and 5.5 on the Expanded Disability Status Scale, and have documented MRI showing brain abnormalities consistent with the condition.

Who cannot participate: People with other serious health conditions that could interfere, those who are pregnant or breastfeeding, anyone with recent infections requiring antibiotics or antiviral medications, those who received other treatments for the condition within a certain period, people with severe allergic reactions to medications, recent participants in other trials, those with substance abuse history, or anyone with conditions that make them unsuitable for the study in the doctor’s opinion.

What the study involves: Participants undergo initial assessments including medical history review and neurological examination, along with brain MRI scans. Baseline evaluations establish starting disability scores and blood samples measure B-cell levels and biomarkers. Treatment involves ocrelizumab infusions (300 mg intravenously every six months), with methylprednisolone (500 mg intravenously) given beforehand to reduce infusion reactions. Participants also take diphenhydramine hydrochloride (50 mg) and paracetamol (500 mg) orally before each infusion. Regular follow-up visits monitor health and treatment response, tracking disability progression time. Final evaluations assess overall disability progression and brain volume changes.

Study medication: Ocrelizumab is a monoclonal antibody administered as an intravenous infusion. It targets and depletes CD20-positive B cells believed to play a role in the abnormal immune response, helping to reduce inflammation and slow disease progression.

Summary

These six clinical trials represent important research efforts to improve treatment options for people living with relapsing forms of the condition. The studies are spread across multiple European countries, with particularly strong representation in Germany, France, Poland, Spain, and Italy.

A notable pattern is the focus on two main medications: ofatumumab and ocrelizumab, both of which are monoclonal antibodies targeting specific immune cells. Four of the six trials investigate ofatumumab in different contexts—from breastfeeding safety to long-term effectiveness, treatment switching, and comparison with first-line therapies. Two trials examine ocrelizumab, including long-term follow-up studies and dose optimization research.

The trials address diverse patient needs, ranging from newly diagnosed individuals who have never received treatment to those who have experienced disease progression despite previous medications. One particularly important study focuses on breastfeeding mothers, addressing a critical knowledge gap about medication safety during this period.

Study durations vary considerably, from 15 months to over 4 years, reflecting both short-term efficacy assessments and long-term safety monitoring. These trials collectively aim to provide comprehensive information about treatment options, helping doctors and patients make informed decisions about managing this challenging condition.

Ongoing Clinical Trials on Multiple sclerosis relapse

  • Study on the Effects of Ozanimod in Patients with Relapsing-Remitting Multiple Sclerosis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Italy

  • Study on Ofatumumab Levels in Breast Milk of Women with Relapsing Multiple Sclerosis

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland

  • Study on the Effectiveness and Tolerability of Ofatumumab Compared to a Drug Combination for Patients with Newly Diagnosed Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • Study on Ofatumumab for Patients with Relapsing Multiple Sclerosis Transitioning from Fumarate-Based Therapies or Fingolimod

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Germany Latvia Poland Portugal Slovakia +2

  • Study on the Effectiveness and Safety of Ocrelizumab, Methylprednisolone, and Diphenhydramine Hydrochloride in Patients with Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Denmark France Hungary +8

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