What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis include immunosuppressants like corticosteroids and azathioprine, monoclonal antibodies such as rituximab, and acetylcholinesterase inhibitors like pyridostigmine. Side effects of immunosuppressants can include increased risk of infections, liver toxicity, and gastrointestinal issues. Monoclonal antibodies may cause infusion reactions, serum sickness, and increased risk of infections. Acetylcholinesterase inhibitors often lead to gastrointestinal disturbances, muscle cramps, and increased salivation. Treatments similar to Satralizumab, which target the immune system, may also carry risks of infections and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, including acetylcholinesterase inhibitors like pyridostigmine, immunosuppressants such as azathioprine and mycophenolate mofetil, and monoclonal antibodies like eculizumab, which targets the complement protein C5. While Satralizumab, an IL-6 receptor inhibitor, is being studied for its efficacy in MG, there are no specific FDA-approved IL-6 receptor inhibitors for MG as of now. The focus remains on therapies that modulate the immune response or improve neuromuscular transmission.

What other types of research exist?

Promising novel alternatives to Satralizumab for Myasthenia Gravis patients include: 1) Efgartigimod, a neonatal Fc receptor (FcRn) antagonist that reduces pathogenic IgG antibodies, 2) Rozanolixizumab, another FcRn antagonist with a similar mechanism, and 3) Rituximab, a monoclonal antibody targeting CD20-positive B cells, which has shown efficacy in refractory MG cases. These alternatives offer different mechanisms of action and have shown potential in clinical trials.

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Satralizumab for Myasthenia Gravis

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)

Ongoing gMG treatment at a stable dose

Must not have

Known disease other than gMG that would interfere with the course and conduct of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing satralizumab, a medication for autoimmune diseases, on patients with generalized myasthenia gravis. The drug aims to improve muscle strength by reducing harmful immune system activity.

Who is the study for?

This trial is for individuals with generalized myasthenia gravis (gMG), a condition causing muscle weakness. Participants must have a confirmed diagnosis, be able to follow the study protocol, and if of childbearing potential, agree to use contraception or abstain from sex during the study and for 3 months after. Exclusions include recent thymectomy, certain vaccinations, pregnancy/breastfeeding intentions within study duration plus 3 months post-study, ocular MG or recent myasthenic crisis.

What is being tested?

The trial is testing Satralizumab's effectiveness compared to a placebo in treating gMG. It will assess how well it works (efficacy), its safety profile, how the body processes it (pharmacokinetics), and what it does in the body (pharmacodynamics).

What are the potential side effects?

While specific side effects are not listed here, common ones associated with medications like Satralizumab may include injection site reactions, increased risk of infections due to immune system suppression, potential liver issues indicated by hepatitis exclusion criteria.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with generalized Myasthenia Gravis.

Select...

I am currently on a stable dose of medication for myasthenia gravis.

Exclusion Criteria

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

Select...

I do not have any health conditions that could affect the study.

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%

Rash

100%

Hypotension

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: SatralizumabExperimental Treatment1 Intervention

Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Satralizumab

2014

Completed Phase 3

~370

0 / 3Eligibility 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

Myasthenia Gravis (MG) treatments primarily target the immune system to reduce the production of antibodies that attack acetylcholine receptors, causing muscle weakness. Acetylcholinesterase inhibitors, like pyridostigmine, increase acetylcholine levels to improve muscle function. Immunosuppressive therapies, such as corticosteroids and biological drugs like rituximab, decrease antibody production. Satralizumab, an IL-6 receptor inhibitor, is being studied for its ability to reduce inflammation and autoantibody production by targeting the IL-6 pathway, which is important in the immune response. Understanding these mechanisms helps tailor treatments to effectively manage MG symptoms and improve patient outcomes.

Neurological adverse events of immune checkpoint blockade: from pathophysiology to treatment.Update in immunosuppressive therapy of myasthenia gravis.