What is the mechanism of action of this treatment?

The most common treatments for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) often involve interleukin-6 (IL-6) receptor inhibitors like Satralizumab. These treatments work by blocking the IL-6 receptor, which is pivotal in the inflammatory cascade that characterizes MOGAD. By inhibiting this receptor, the treatments aim to reduce inflammation and prevent disease relapses. This mechanism is crucial for MOGAD patients as it helps to minimize neurological damage caused by recurrent inflammatory episodes, thereby preserving neurological function and improving overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) include immunosuppressive and immunomodulatory therapies such as Satralizumab, which is an Interleukin-6 Receptor Inhibitor. Known side effects of Satralizumab and similar treatments can include injection site reactions, increased risk of infections, liver enzyme abnormalities, and gastrointestinal symptoms like nausea. Patients may also experience headaches and nasopharyngitis. It is important to monitor for these side effects and discuss them with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD). However, treatments targeting similar mechanisms, such as Interleukin-6 Receptor Inhibitors, are being studied. Satralizumab, an Interleukin-6 Receptor Inhibitor, is currently under investigation for its efficacy in treating MOGAD. This class of drugs is also used in other autoimmune conditions, such as neuromyelitis optica spectrum disorder (NMOSD), where Satralizumab has received FDA approval.

What other types of research exist?

Promising novel alternatives to Satralizumab for MOGAD patients in 2024 may include other monoclonal antibodies targeting different immune pathways, such as Rituximab (a CD20 inhibitor), Eculizumab (a complement inhibitor), and Tocilizumab (another IL-6 receptor inhibitor). Additionally, therapies like Inebilizumab (a CD19 inhibitor) and novel small molecule inhibitors targeting specific immune cells or cytokines involved in MOGAD are also being explored.

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Monoclonal Antibodies

Satralizumab for MOG Antibody Disease (Meteoroid Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening

Participants who are aged >=12 years at the time of signing Informed Consent Form

Must not have

Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study

Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing satralizumab, a medication that helps prevent relapses in patients with MOGAD by reducing inflammation and stopping the immune system from attacking the nervous system.

Who is the study for?

This trial is for people aged 12 and older with confirmed MOGAD who've had at least one relapse in the past year or two in the last two years. Participants must not be pregnant, agree to use contraception, have a certain level of disability (EDSS score 0-6.5), and good vision (BCVA better than 20/800). They can't join if they have other antibodies, infections, hepatitis B/C, are pregnant/breastfeeding, recently vaccinated with live vaccines, severe allergies to biologics or need high doses of steroids.

What is being tested?

The study tests whether Satralizumab is more effective than a placebo in preventing relapses in patients with MOGAD. It measures the time until a participant has their first relapse after starting treatment during a double-blind period where neither doctors nor participants know who's getting Satralizumab or placebo.

What are the potential side effects?

Satralizumab may cause side effects such as potential allergic reactions due to it being a biological agent. The exact side effects aren't listed here but typically include symptoms related to immune system changes since it targets specific pathways involved in inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on or am currently taking long-term immune system suppression medication for MOGAD.

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I am 12 years old or older.

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My disability level allows me to walk at least 100 meters without aid or rest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any other illness needing strong steroids for more than 3 weeks.

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My blood test shows I have AQP4 antibodies.

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I have not received a live vaccine in the last 6 weeks.

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I do not have any active infections.

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I do not have active or untreated latent tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884

100%

Hypotension

100%

Rash

100%

Haemorrhoids

100%

White blood cell count decreased

100%

Rhinitis

100%

Localised infection

100%

Lymphocyte percentage decreased

100%

Monocyte count increased

100%

White blood cell count increased

100%

Pruritus

100%

Headache

100%

Diarrhoea

100%

Abdominal pain

100%

Tonsillitis

100%

Dysmenorrhoea

100%

Rectal haemorrhage

100%

Ear infection

100%

Neutrophil count increased

100%

Oropharyngeal pain

100%

Haemoglobin decreased

100%

Neutrophil percentage increased

100%

Platelet count increased

100%

Lymphocyte percentage increased

100%

Neutrophil count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Satralizumab Open-Label Period

Placebo + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment Double Blind Period

Placebo + Baseline Treatment Double Blind Period

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group A: SatralizumabExperimental Treatment1 Intervention

In the double-blind treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Group II: Group B: PlaceboPlacebo Group1 Intervention

In the double-blind treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Satralizumab

2014

Completed Phase 3

~370

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) often involve interleukin-6 (IL-6) receptor inhibitors like Satralizumab. These treatments work by blocking the IL-6 receptor, which is pivotal in the inflammatory cascade that characterizes MOGAD. By inhibiting this receptor, the treatments aim to reduce inflammation and prevent disease relapses. This mechanism is crucial for MOGAD patients as it helps to minimize neurological damage caused by recurrent inflammatory episodes, thereby preserving neurological function and improving overall quality of life.

Future research directions in multiple sclerosis therapies.