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

Verified siteRegistered drugNo placebo
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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 a condition known as Relapsing-Remitting Multiple Sclerosis (RRMS). This is a type of multiple sclerosis where patients experience episodes of new or increasing symptoms followed by periods of partial or complete recovery. The study will compare two treatments: ABP 692 and Ocrevus (also known as ocrelizumab), which are both given as an infusion, meaning they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare how these two treatments work in the body, their effects on the disease, and their safety. Participants will receive either ABP 692 or Ocrevus, and the study will monitor how the treatments affect the number of new active brain lesions, which are areas of damage in the brain that can be seen using a special imaging technique called MRI (Magnetic Resonance Imaging). The study will last for about 48 weeks, with regular check-ups to assess the treatments' effects and safety.

Throughout the study, participants will receive regular infusions and undergo various assessments to monitor their health and the progression of their condition. The goal is to determine if ABP 692 is as effective and safe as Ocrevus in treating RRMS. This information could help improve treatment options for people living with this condition.

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

    The study begins with an initial assessment to confirm eligibility. This includes a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to specific criteria, a disability score between 0 and 5.5, and recent activity of the condition.

    The participant must be neurologically stable, with no relapses for at least 28 days before starting the trial.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either ABP 692 or Ocrevus (ocrelizumab). This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves an intravenous infusion of the assigned medication. The specific product used is either Ocrevus 300 mg concentrate for solution for infusion or ABP 692.

    The infusion is administered according to the study protocol, which includes monitoring the participant's response and any side effects.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for the pharmacokinetics (how the drug is processed in the body) and pharmacodynamics (the effects of the drug) over a period of 24 weeks.

    Regular assessments are conducted to track the suppression of new active brain lesions using MRI scans at weeks 4, 8, 12, 16, 20, and 24.

  5. Step 5

    Completion of study

    The study is estimated to conclude by July 2, 2027. Participants will have completed all required assessments and treatments by this time.

Who can join the trial?

7 criteria

  • The patient must have a diagnosis of **Relapsing-remitting Multiple Sclerosis (RRMS)**, which is a type of multiple sclerosis where symptoms come and go.
  • The patient must meet the **revised McDonald Criteria 2017**, which are guidelines used to diagnose multiple sclerosis.
  • The patient must have a score on the **Expanded Disability Status Scale (EDSS)** between 0 and 5.5. This scale measures the level of disability in people with multiple sclerosis.
  • There must be evidence of recent multiple sclerosis activity, as defined by the study protocol.
  • The patient must be **neurologically stable**, meaning they have not had a relapse, or worsening of symptoms, for 28 days or less before joining the study.
  • The study is open to both male and female participants.
  • The study is for adults aged 18 years and older.

Who cannot join the trial?

4 criteria

  • Patients with any other type of **Multiple Sclerosis** besides **Relapsing-remitting Multiple Sclerosis** cannot participate. **Multiple Sclerosis** is a condition that affects the brain and spinal cord, and **relapsing-remitting** means it comes and goes.
  • 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 part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the health requirements set by the study organizers cannot participate. These requirements ensure the safety and effectiveness of the study.
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Investigated drugs

  • ABP 692

    is an investigational medication being studied for its effects on relapsing-remitting multiple sclerosis. It is being compared to an existing treatment to see if it works in a similar way in the body and has similar effects on the disease.

  • Ocrevus® (Ocrelizumab)

    is a medication already approved for the treatment of relapsing-remitting multiple sclerosis. It works by targeting specific cells in the immune system to reduce inflammation and prevent new brain lesions, which are common in multiple sclerosis. This study is comparing the effects of ABP 692 to Ocrevus® to ensure they are similar in terms of how they work and their safety profiles.

What is already known about the treatment

ABP 692 – This medication is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials to assess its effectiveness and safety compared to Ocrevus® (Ocrelizumab) for treating relapsing-remitting multiple sclerosis. The main therapeutic use of ABP 692 is to manage this form of multiple sclerosis, which is characterized by episodes of new or increasing neurological symptoms. At the molecular level, ABP 692 works by targeting and depleting certain immune cells that are involved in the disease process. It is classified as a monoclonal antibody, a type of medication designed to interact with specific proteins in the body.

Investigated diseases

Relapsing-remitting Multiple Sclerosis – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During a relapse, individuals may experience symptoms such as vision problems, muscle weakness, or coordination difficulties. These symptoms can vary in severity and duration. After a relapse, there is a remission phase where symptoms may improve or disappear entirely. However, over time, some symptoms may persist and accumulate, leading to gradual disability. The disease course is unpredictable, with the frequency and severity of relapses varying among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512914-16-00Protocol code20230309Estimated enrolment211 patientsSponsorAmgen Inc.

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