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Study on the Effectiveness and Safety of Rozanolixizumab for Adults with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD)

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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 Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). This is a rare neurological disorder where the immune system mistakenly attacks a protein in the central nervous system, leading to inflammation and damage. The study is testing a treatment called Rozanolixizumab, also known by its code name UCB7665. This medication is given as a solution for injection under the skin, a method known as subcutaneous use.

The purpose of the study is to evaluate how effective and safe Rozanolixizumab is for treating adults with MOGAD. Participants in the study will be randomly assigned to receive either Rozanolixizumab or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The study will also include an open-label extension period, where all participants will have the opportunity to receive Rozanolixizumab.

Throughout the study, participants will be monitored for any changes in their condition and any side effects they may experience. The study will track the time it takes for participants to experience a relapse of their symptoms and will also record any adverse events that occur. The study aims to provide valuable information on the long-term safety and effectiveness of Rozanolixizumab for people living with MOGAD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age, diagnosis, and clinical stability. Participants must be between 18 and 89 years old, have a confirmed diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD), and be clinically stable.

  2. Step 2

    Double-blind treatment period

    Participants receive either the investigational medication, rozanolixizumab, or a placebo. Rozanolixizumab is administered as a 140 mg/ml solution for injection under the skin (subcutaneous use).

    The primary goal is to measure the time from randomization to the first relapse. Secondary goals include changes in visual acuity and disability, as well as the number of hospitalizations related to MOG-AD.

  3. Step 3

    Open-label extension period

    Participants who complete the double-blind period may enter an open-label extension period where all receive rozanolixizumab.

    The focus is on monitoring the incidence of any adverse events and the annualized relapse rate.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants are regularly monitored for any side effects or changes in their condition. This includes assessments of visual acuity and disability status.

Who can join the trial?

4 criteria

  • Participants must be between 18 and 89 years old at the time of signing the informed consent.
  • Must have a confirmed diagnosis of Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD), which is a specific condition diagnosed using certain criteria.
  • Must have a history of relapsing MOG-AD, meaning the condition has come back at least once in the last 12 months, and have a positive test result for MOG antibodies using a special test called a cell-based assay (CBA) within 6 months before starting the trial.
  • Must be clinically stable, meaning their condition is not changing, at the time of the Screening Visit and during the Screening Period.

Who cannot join the trial?

3 criteria

  • Participants who do not have **myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)** cannot join the study. This is a specific condition related to the immune system affecting the nervous system.
  • Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants who are part of a vulnerable population, meaning they might need special protection or care, are not eligible for this study.
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Investigated drugs

Rozanolixizumab is a medication being studied for its effectiveness in treating adults with a condition called myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD). This condition affects the nervous system, and the medication aims to help manage the symptoms by targeting specific antibodies involved in the disease. The study is designed to assess how well this medication works and how safe it is for patients.

What is already known about the treatment

Rozanolixizumab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD). It is in the phase 3 stage of clinical trials, which means it is being tested for safety and efficacy in a larger group of participants. Rozanolixizumab works by targeting and reducing the activity of certain antibodies that are believed to contribute to the symptoms of MOG-AD. It is classified as a monoclonal antibody, which is a type of medication designed to interact with specific proteins in the immune system.

Investigated diseases

Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) – This is a rare neurological disorder characterized by inflammation in the central nervous system, primarily affecting the optic nerves and spinal cord. It is associated with the presence of antibodies against myelin oligodendrocyte glycoprotein, a component of the myelin sheath that insulates nerve fibers. The disease often presents with symptoms such as vision problems, muscle weakness, and sensory disturbances. MOG-AD can have a relapsing course, where symptoms may improve and then worsen again over time. The progression of the disease can vary significantly among individuals, with some experiencing frequent relapses and others having long periods of remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509237-39-00Protocol codeMOG001Estimated enrolment125 patientsSponsorUCB Biopharma

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