What side effects are associated with this type of intervention?

In the context of Myasthenia Gravis, treatments such as rozanolixizumab and inebilizumab have been studied. Rozanolixizumab's side effects include nasopharyngitis, headache, and mild transient diarrhea. Inebilizumab's side effects were not detailed in the provided context, but generally, treatments for Myasthenia Gravis can include side effects like gastrointestinal discomfort, allergic reactions, and injection-site reactions. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for Myasthenia Gravis include acetylcholinesterase inhibitors like pyridostigmine, which provide symptomatic relief by improving neuromuscular transmission. Immunosuppressive agents such as azathioprine, mycophenolate mofetil, and cyclosporine are also used to manage the disease by targeting the underlying immune dysregulation. Additionally, eculizumab, a complement inhibitor, has been approved for patients with refractory generalized Myasthenia Gravis. These treatments aim to reduce symptoms and improve the quality of life for patients with Myasthenia Gravis.

What other types of research exist?

Promising novel alternatives for Myasthenia Gravis treatment in 2024 include monoclonal antibodies (mAbs) targeting anti-acetylcholine receptor (AChR) antibodies and B-cell targeted therapies such as rituximab. These therapies have shown encouraging results and are part of a precision medicine approach for better outcomes.

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Monoclonal Antibodies

Inebilizumab for Myasthenia Gravis (MINT Trial)

Phase 3

Waitlist Available

Research Sponsored by Viela Bio

Eligibility Criteria Checklist

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

Must have

Diagnosis of MG with anti-AChR or anti-MuSK antibody

MGFA Clinical Classification Class II, III, or IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests a new treatment for Myasthenia Gravis in patients with specific antibodies. It aims to see if the new treatment improves muscle strength.

Who is the study for?

This trial is for people with Myasthenia Gravis, a condition causing muscle weakness. Participants must have certain antibodies and scores indicating moderate to severe symptoms. They should be on stable doses of specific treatments like corticosteroids or immunosuppressants but not others like cyclosporine or high-dose acetylcholinesterase inhibitors.

What is being tested?

The study tests Inebilizumab against a placebo in patients with Myasthenia Gravis. It's randomized (participants are assigned by chance), double-blind (neither the researchers nor participants know who gets what treatment), and placebo-controlled to compare effects accurately.

What are the potential side effects?

While the side effects of Inebilizumab aren't detailed here, similar medications can cause infusion reactions, infections due to immune system suppression, liver issues, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with MG and tested positive for anti-AChR or anti-MuSK antibodies.

Select...

My myasthenia gravis is moderate to severe.

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

Awards & Highlights

Pivotal Trial

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

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Inebilizumab, (MuSK-Ab+) MGExperimental Treatment1 Intervention

Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Group II: Inebilizumab, (AChR-Ab+) MGExperimental Treatment1 Intervention

Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Group III: Placebo, (MuSK-Ab+) MGPlacebo Group1 Intervention

Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Group IV: Placebo, (AChR-Ab+) MGPlacebo Group1 Intervention

Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

0 / 2Eligibility 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 Myasthenia Gravis (MG) include immunotherapy, thymectomy, and symptomatic therapies. Immunotherapy targets the dysregulated immune system by using agents that suppress or modulate immune responses, thereby reducing the production of antibodies that attack the neuromuscular junction. Thymectomy, the surgical removal of the thymus gland, is believed to reduce the production of these harmful antibodies and has been shown to improve long-term remission rates. Symptomatic therapies, such as acetylcholinesterase inhibitors, increase the availability of acetylcholine at the neuromuscular junction, improving muscle strength. These treatments are crucial for MG patients as they aim to restore immune balance, alleviate symptoms, and achieve long-term remission, significantly improving quality of life.

Advances in the understanding of disease mechanisms of autoimmune neuromuscular junction disorders.Knowledge mapping of targeted immunotherapy for myasthenia gravis from 1998 to 2022: A bibliometric analysis.Therapeutic modalities in small cell lung cancer: a paradigm shift after decades of quiescence.