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Study on the Effects of Obexelimab for Patients with Relapsing Multiple Sclerosis

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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 treatment called Obexelimab in patients with Relapsing Multiple Sclerosis (RMS). Multiple sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. The study will compare the effects of Obexelimab, which is given as a subcutaneous injection (an injection under the skin), to a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how well Obexelimab works in preventing new lesions in the brain, which are areas of damage that can be seen on an MRI (Magnetic Resonance Imaging) scan. These lesions are often associated with relapses or flare-ups of symptoms in multiple sclerosis. Participants in the study will receive weekly injections and will undergo regular MRI scans to monitor the development of new lesions over a period of several weeks.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving Obexelimab and who is receiving the placebo. This helps ensure that the results are not biased. The trial will also monitor for any side effects or adverse events that may occur during the treatment period. The overall goal is to determine the safety and effectiveness of Obexelimab in managing relapsing multiple sclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A brain MRI scan is performed to check for specific types of brain lesions associated with relapsing multiple sclerosis.

  2. Step 2

    Treatment phase

    The treatment phase involves receiving a weekly subcutaneous injection of either obexelimab or a placebo. The injection is administered under the skin.

    The duration of this phase is 12 weeks, with injections given once a week.

  3. Step 3

    Monitoring and evaluations

    Throughout the study, regular monitoring is conducted to assess the effect of the treatment. This includes MRI scans at Week 4, Week 8, and Week 12 to detect any new or enlarging brain lesions.

    Blood tests are performed to measure serum levels of certain proteins, such as neurofilament light chain (NfL), at Week 12.

  4. Step 4

    Safety assessments

    Safety assessments are carried out to monitor for any adverse events or side effects. This includes tracking any new symptoms or health issues that arise during the study period.

    Participants are asked to report any adverse events immediately to ensure proper management and care.

  5. Step 5

    End of study

    At the end of the 12-week treatment period, a final evaluation is conducted. This includes a comprehensive review of all collected data and a final MRI scan.

    Participants are provided with information about the study's findings and any next steps regarding their treatment or care.

Who can join the trial?

15 criteria

  • Must be able to give signed informed consent, which means agreeing to follow the study's rules and requirements.
  • Must be a male or female between the ages of 18 and 60, inclusive, at the time of signing the consent form.
  • Must have a diagnosis of **Relapsing Multiple Sclerosis (RMS)**, which can be either relapsing-remitting or secondary progressive with relapses, according to specific medical criteria.
  • Must have an **EDSS** (Expanded Disability Status Scale) score of 5.5 or less at the screening visit. This is a scale used to measure disability in people with multiple sclerosis.
  • Must have documentation of at least one of the following:
    • At least one relapse within the previous year.
    • Two or more relapses within the past two years.
    • At least one active **Gd-enhancing brain lesion** on an MRI scan within the past six months before screening. This refers to a specific type of brain scan result.
    • If female, must not be pregnant or breastfeeding and must meet one of the following conditions:
      • Not a woman of childbearing potential.
      • If of childbearing potential, must agree to use contraception as advised until at least eight weeks after the last dose of the study medication.
      • Must have a negative pregnancy test at screening and before the first dose of the study medication.
      • Must agree not to donate eggs until at least eight weeks after the last dose of the study medication.
      • If male, must agree to one of the following:
        • Abstain from intercourse.
        • Use contraception as advised until at least eight weeks after the last dose of the study medication.
        • Be surgically sterile for the duration of the study.
        • Must agree not to donate sperm until at least eight weeks after the last dose of the study medication.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of multiple sclerosis other than relapsing multiple sclerosis cannot participate. Relapsing multiple sclerosis is a form of the disease where symptoms come and go.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are not able to undergo MRI scans cannot participate. MRI, or magnetic resonance imaging, is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
  • Patients who have other medical conditions that might interfere with the study cannot participate. These conditions are determined by the study organizers.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different treatments.
  • Patients who have had a recent infection or illness that could affect the study results cannot participate. This is to ensure accurate and reliable results.
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Investigated drugs

Obexelimab is a medication being studied for its potential to help patients with relapsing multiple sclerosis. It is given as an injection under the skin once a week. The goal of using obexelimab in this trial is to see if it can prevent new lesions in the brain, which are detected using MRI scans. These lesions are a sign of disease activity in multiple sclerosis, and reducing them could mean better outcomes for patients.

What is already known about the treatment

Obexelimab – Obexelimab is administered through a subcutaneous injection, meaning it is given under the skin. It is currently being studied in clinical trials for its potential use in treating relapsing multiple sclerosis, a condition characterized by episodes of new or worsening neurological symptoms. The medication works by targeting specific immune cells to reduce inflammation and prevent the formation of new lesions in the brain, as detected by MRI scans. Obexelimab is classified as an immunomodulatory agent, which means it helps to regulate or normalize the immune system's response.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease can cause a wide range of symptoms, including fatigue, vision problems, muscle weakness, and difficulties with coordination and balance. Over time, relapses may lead to a gradual increase in disability. The exact cause of relapsing multiple sclerosis is unknown, but it is believed to involve an abnormal immune response that attacks the protective covering of nerve fibers. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512707-40-00Protocol codeZB012-02-002Estimated enrolment145 patientsSponsorZenas Biopharma (USA) LLC

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