Not recruitingRare disease

Study on the Effects of Satralizumab for Patients with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

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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 disorder that affects the nervous system, particularly the brain, spinal cord, and optic nerves. The study is testing a treatment called Satralizumab, which is given as a solution for injection. Satralizumab is being evaluated to see how well it works and how safe it is for people with MOGAD. Some participants will receive Satralizumab, while others will receive a placebo, which looks like the treatment but does not contain the active medicine.

The purpose of the study is to understand the effects of Satralizumab when used alone or alongside other treatments that patients might already be taking. The study will follow participants over a period of time to observe any changes in their condition, particularly looking at the time it takes for a relapse, or return of symptoms, to occur. Participants will receive injections under the skin, and the study will monitor various health indicators, including any side effects and changes in their condition.

Throughout the study, participants will undergo regular check-ups and tests, such as MRI scans, to track the progress of their disease and the impact of the treatment. The study aims to provide valuable information on whether Satralizumab can help manage MOGAD more effectively and improve the quality of life for those affected by this condition. The trial is expected to continue for several years to gather comprehensive data on the treatment's effectiveness and safety.

The research process

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

Step 1
Joining the study
Upon joining the study, the participant is confirmed to have Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and meets the inclusion criteria, such as age and health status.
Step 2
Randomization
The participant is randomly assigned to receive either the medication satralizumab or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
Step 3
Treatment administration
The participant receives satralizumab as a subcutaneous injection. The dosage is 120 mg, administered according to the study's schedule. The exact frequency and duration of administration are determined by the study protocol.
Step 4
Monitoring and assessments
Throughout the study, the participant undergoes regular monitoring to assess the efficacy and safety of the treatment. This includes tracking the time to the first occurrence of a MOGAD relapse and evaluating any changes in health status.
Additional assessments may include MRI scans to check for active lesions, cognitive tests, and monitoring of vital signs, weight, and laboratory test results.
Step 5
Completion of the study
The study is estimated to conclude by December 27, 2027. Upon completion, the participant's health and treatment outcomes are evaluated to determine the overall efficacy and safety of satralizumab.

Who can join the trial?

6 criteria

Participants must be **12 years or older** at the time of signing the consent form and have a confirmed diagnosis of **Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)**. They should have had at least one MOGAD relapse in the past 12 months or at least two attacks in the past 24 months before the screening.
Participants should have an **Expanded Disability Status Scale (EDSS)** score between **0 and 6.5** at screening. The EDSS is a method to measure disability in people with multiple sclerosis and similar conditions.
Participants must have **high-contrast visual acuity (HCVA)** better than **20/800** in each eye at screening. This means their vision should be better than a very low level of sight.
Participants can either not be on any ongoing chronic **immunosuppressant treatment (IST)** for MOGAD at the time of screening or be receiving ongoing treatment with **azathioprine (AZA)**, **mycophenolate mofetil (MMF)**, **oral corticosteroids (OCS)**, or a combination of OCS and AZA or MMF before and at the time of screening. Immunosuppressant treatments are medications that reduce the activity of the immune system.
Participants should have no **contraindications** to rescue treatments and no contraindications to **MRI**. Contraindications are specific situations where a drug or procedure should not be used because it may be harmful.
For women who can have children: Participants must agree to remain abstinent or use adequate **contraception** during the treatment period and for at least 3 months after the final dose of **satralizumab**. Contraception refers to methods used to prevent pregnancy.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to the study medication or its ingredients.
Patients who are currently participating in another clinical trial.
Patients with a history of certain other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have received certain treatments or medications recently that could affect the study results.
Patients with a history of substance abuse or addiction.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients with a history of certain infections that could pose a risk during the study.
Patients with a compromised immune system, which means their body's defense against infections is weakened.
Patients who have had a recent vaccination with a live vaccine, which is a type of vaccine that uses a weakened form of the germ that causes a disease.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Hospices Civils De Lyon
Lyon, France
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany
Responsive
Universita' Degli Studi Di Verona
Verona, Italy

Trial locations

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Investigated drugs

Satralizumab is a medication being studied for its effectiveness in treating patients with a condition called Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). This medication is being tested to see if it can help prevent relapses of the disease when used alone or in combination with other treatments. The study aims to understand how well satralizumab works, how safe it is for patients, and how it behaves in the body.

What is already known about the treatment

Satralizumab – Satralizumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently being studied in clinical trials for its effectiveness in treating Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). The medication works by targeting and inhibiting the interleukin-6 receptor, which plays a role in the inflammatory process associated with MOGAD. Satralizumab is classified as a monoclonal antibody, a type of biologic drug designed to modulate the immune system's response.

Investigated diseases

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) – This is a rare autoimmune disorder where the immune system mistakenly attacks the myelin sheath, a protective covering of nerve fibers in the central nervous system. The disease can lead to inflammation and damage in the optic nerves, spinal cord, and brain. Symptoms often include vision problems, muscle weakness, and sensory disturbances. The progression of MOGAD can vary, with some individuals experiencing relapses or flare-ups of symptoms. These relapses can result in new or worsening neurological symptoms. The condition is characterized by the presence of antibodies against myelin oligodendrocyte glycoprotein.