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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Hospices Civils De Lyon	Lyon	France
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Bicetre Hospital	Le Kremlin-Bicetre	France
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Ndqkyppdgmus Zrogim Oweyme Zswrjkkraw Wjkweepncxppzsqbwjmw Pnibnlrv Lztrvzmw Suhykbwc Lrra Sreysbjfcnnz	Katowice	Poland
Ucngdgslyuw Wrevmlelgdcxwlh &daijzs Vawrvovuo Kyzuxtt ugl Jhxfwferacqy Dritldp	Datteln	Germany
Uqgouyfdrtnpsgbxfqkeg Dxmnabnxbos Azf	Duesseldorf	Germany
Kbljxcgy dek Uujtjfvrermd Mkyzruzr Arb	Munich	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.08.2022
Germany	Not recruiting	30.08.2022
Italy	Not recruiting	30.08.2022
Poland	Not recruiting	30.08.2022

Trial locations

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.

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.

Trial ID:

2023-507196-22-00

Protocol code:

WN43194

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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