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Study on Masitinib for Treating Primary or Secondary Progressive Multiple Sclerosis in Patients Without Relapse

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called masitinib in treating a condition known as Multiple Sclerosis (MS). Specifically, the study is looking at two types of MS: primary progressive and secondary progressive, both of which do not involve relapses. Masitinib is a type of drug known as a tyrosine kinase inhibitor, which is taken orally in the form of a coated tablet. The study will compare the effects of masitinib to a placebo, which is a substance with no active medication, to see how effective and safe masitinib is for patients with these types of MS.

The purpose of the study is to evaluate how well masitinib works and how safe it is for patients with primary progressive or secondary progressive MS without relapses. Participants in the study will take masitinib at a dose that can be increased up to 4.5 milligrams per kilogram of body weight per day. The study will last for 96 weeks, during which time participants will be monitored for any changes in their condition. This includes looking at how their disability progresses, using a scale called the Expanded Disability Status Scale (EDSS), and assessing their overall quality of life.

Throughout the study, various assessments will be conducted, such as timed walking tests, hand dexterity tests, and brain scans using MRI to check for changes in brain volume and lesions. Additionally, the study will measure levels of certain proteins in the blood that may indicate changes in the disease. The goal is to gather comprehensive data on how masitinib affects the progression of MS and the overall well-being of the participants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The study begins with the administration of masitinib or a placebo. The medication is taken orally in the form of a coated tablet.

    The initial dosage is 3.0 mg/kg/day of masitinib. This dosage is maintained for the first four weeks.

  2. Step 2

    Dose escalation

    After four weeks, the dosage of masitinib is increased to 4.5 mg/kg/day.

    This increased dosage is continued for the remainder of the study period.

  3. Step 3

    Ongoing assessments

    Throughout the study, various assessments are conducted to monitor progress and health status.

    These include the Expanded Disability Status Scale (EDSS) to measure disability progression, and other tests such as the Timed 25-foot walk and Nine-hole peg test to assess physical abilities.

  4. Step 4

    Brain MRI assessments

    Brain MRI scans are performed at the start, at Week 48, and at Week 96 to evaluate brain volume and lesions.

    These scans help in assessing changes in brain structure over the course of the study.

  5. Step 5

    Quality of life assessments

    Quality of life is evaluated using the Multiple Sclerosis Quality of Life (MSQOL)-54 instrument.

    Additional assessments include the Modified Fatigue Impact Scale (MFIS) and the Hamilton Depression Rating Scale (HAM-D).

  6. Step 6

    Biomarker analysis

    In a subgroup of 200 patients, levels of specific biomarkers such as Neurofilament Light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) are measured.

    These measurements are taken at the start and at Week 96 to evaluate changes over time.

  7. Step 7

    Study completion

    The study is designed to last for 96 weeks.

    Upon completion, final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

10 criteria

  • Patients must have either primary progressive or secondary progressive multiple sclerosis. This means their condition has been gradually worsening over time without any relapses or sudden worsening.
  • Symptoms must have started at least five years before joining the study, and there should be no relapses diagnosed for at least two years before the screening.
  • Patients need to have an Expanded Disability Status Scale (EDSS) score between 3.0 and 6.0. This scale measures the level of disability in people with multiple sclerosis.
  • There should be a progression in the EDSS score by at least 1 point without any improvement during the two years before screening.
  • No T1 Gadolinium-enhancing brain lesions should be present at the start of the study. These are specific types of brain lesions that can be seen in an MRI scan.
  • Participants must be between 18 and 65 years old.
  • Participants must weigh more than 45 kg and have a Body Mass Index (BMI) between 18 and 35. BMI is a measure of body fat based on height and weight.
  • Female participants who can have children must have a negative pregnancy test and agree to use effective birth control methods during the study and for 8 months after the last treatment. Male participants with partners who can have children must also agree to use effective birth control methods during the study and for 5 months after the last treatment.
  • Participants must be able to understand and willing to sign a consent form before any study procedures. If they cannot sign due to their condition, a legally authorized representative can sign on their behalf after confirming the participant's agreement.
  • Participants must be willing and able to follow the study protocol and attend scheduled visits.

Who cannot join the trial?

7 criteria

  • Patients who have had a recent **relapse** of their condition. A relapse is when symptoms suddenly get worse.
  • Patients who are currently taking other medications that might interfere with the study treatment.
  • Patients with other serious health conditions that could affect their safety during the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Masitinib is a medication being studied for its potential to treat patients with primary progressive or secondary progressive multiple sclerosis without relapse. It is taken orally and works by targeting certain cells in the immune system that may be involved in the progression of multiple sclerosis. The goal of using masitinib in this trial is to assess its effectiveness and safety in slowing down or managing the symptoms of this type of multiple sclerosis.

What is already known about the treatment

Masitinib – Masitinib is administered orally and is currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating primary progressive or secondary progressive multiple sclerosis without relapse. This medication is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for masitinib in this trial is multiple sclerosis, specifically the progressive forms without relapse. At the molecular level, masitinib works by inhibiting certain enzymes called tyrosine kinases, which play a role in the activity of immune cells that can contribute to the progression of multiple sclerosis. It is classified pharmacologically as a tyrosine kinase inhibitor.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapses. There are different types of Multiple Sclerosis, including primary progressive and secondary progressive, which are marked by a gradual worsening of symptoms over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516672-16-00Protocol codeAB20009Estimated enrolment145 patientsSponsorAb Science

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