What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis include corticosteroids, immunosuppressants, intravenous immunoglobulin (IVIG), and plasmapheresis. Corticosteroids can cause weight gain, diabetes, hypertension, and osteoporosis. Immunosuppressants like azathioprine and mycophenolate mofetil may lead to increased infection risk, liver toxicity, and gastrointestinal issues. IVIG can cause headaches, fever, and allergic reactions, while plasmapheresis may result in citrate reactions and vascular access complications. For treatments similar to Batoclimab, such as other FcRn inhibitors, side effects may include injection site reactions, infections, and potential hypersensitivity reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, focusing on immunomodulation and symptomatic relief. Pyridostigmine, an acetylcholinesterase inhibitor, is commonly used for symptomatic management. Immunosuppressants like azathioprine and mycophenolate mofetil, as well as corticosteroids, are used to reduce immune system activity. Intravenous immunoglobulin (IVIG) and plasmapheresis are employed for rapid symptom control during severe exacerbations. More recently, eculizumab, a complement inhibitor, has been approved for patients with anti-acetylcholine receptor antibody-positive MG. While Batoclimab, an FcRn inhibitor, is still under investigation, it represents a novel approach by targeting the neonatal Fc receptor to reduce pathogenic IgG antibodies, potentially offering a new therapeutic avenue for MG.

What other types of research exist?

Promising novel alternatives to Batoclimab for Myasthenia Gravis patients include: 1) Efgartigimod, an FcRn antagonist that has shown efficacy in reducing MG symptoms by lowering pathogenic IgG levels. 2) Rozanolixizumab, another FcRn inhibitor that has demonstrated positive results in clinical trials for MG. 3) Rituximab, a monoclonal antibody targeting CD20, which has been used off-label and is being studied for its effectiveness in MG. These alternatives offer different mechanisms of action and have shown potential in improving outcomes for MG patients.

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Monoclonal Antibodies

Batoclimab for Myasthenia Gravis

Q: What is the mechanism of action of this treatment?

The most common treatments for Myasthenia Gravis (MG) include acetylcholinesterase inhibitors, immunosuppressive drugs, and emerging biological therapies like FcRn inhibitors. Acetylcholinesterase inhibitors, such as pyridostigmine, increase the availability of acetylcholine at the neuromuscular junction, improving muscle contraction. Immunosuppressive drugs, including corticosteroids and other agents like azathioprine, reduce the immune system's attack on acetylcholine receptors. FcRn inhibitors, such as batoclimab, work by reducing the levels of pathogenic IgG antibodies, thereby decreasing the autoimmune response. These treatments are crucial for MG patients as they help manage symptoms, improve muscle strength, and reduce the frequency of myasthenic crises, significantly enhancing the quality of life.

Phase 3

Waitlist Available

Research Sponsored by Immunovant Sciences GmbH

Eligibility Criteria Checklist

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

Must have

Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits

Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit

Must not have

Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies) within the past year

Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) to week 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing batoclimab, a medication given by injection, in patients with generalized Myasthenia Gravis who have specific antibodies. The goal is to see if it can improve their muscle strength and daily activities by lowering harmful antibodies. The study will also check if the benefits last over time. Batoclimab is being tested for its safety and potential efficacy in Chinese patients with generalized myasthenia gravis.

Who is the study for?

Adults over 18 with generalized Myasthenia Gravis (gMG) who experience muscle weakness. They should have specific scores on the QMG and MG-ADL scales, indicating mild to severe gMG. Those who've had a recent myasthenic crisis, thymectomy, untreated malignant thymoma, or certain immunosuppressive treatments are excluded.

What is being tested?

The trial is testing Batoclimab's effectiveness for gMG at different doses: 680 mg weekly or 340 mg weekly/bi-weekly versus placebo. It has three periods: initial treatment randomization, dose adjustment re-randomization for responders, and long-term extension for sustained response.

What are the potential side effects?

While not specified here, potential side effects of Batoclimab may include injection site reactions like pain or swelling, allergic reactions ranging from rash to anaphylaxis, infections due to immune system suppression and possibly others as it targets the immune system.

Eligibility Criteria

Inclusion Criteria

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

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My myasthenia gravis symptoms are moderate to severe.

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My myasthenia gravis is classified as mild to severe.

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I am 18 years old or older.

Exclusion Criteria

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

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I haven't had treatments that weaken my immune system in the past year.

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I had my thymus gland removed less than 6 months ago or will have it removed during the study.

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I have an active or untreated cancer in my thymus gland.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants

Secondary study objectives

Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants

Number of Participants with Clinically Significant Changes in Laboratory Results

Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements

+1 more

Awards & Highlights

Pivotal Trial

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

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Batoclimab Maintenance Dose 2 (Period 2)Experimental Treatment1 Intervention

Group II: Batoclimab Maintenance Dose 1 (Period 2)Experimental Treatment1 Intervention

Group III: Batoclimab Induction Dose 2 (Period 1)Experimental Treatment1 Intervention

Group IV: Batoclimab Induction Dose 1 (Period 1)Experimental Treatment1 Intervention

Group V: Placebo Induction Dose (Period 1)Placebo Group1 Intervention

Group VI: Placebo Maintenance Dose (Period 2)Placebo Group1 Intervention

0 / 6Eligibility 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 acetylcholinesterase inhibitors, immunosuppressive drugs, and emerging biological therapies like FcRn inhibitors. Acetylcholinesterase inhibitors, such as pyridostigmine, increase the availability of acetylcholine at the neuromuscular junction, improving muscle contraction. Immunosuppressive drugs, including corticosteroids and other agents like azathioprine, reduce the immune system's attack on acetylcholine receptors. FcRn inhibitors, such as batoclimab, work by reducing the levels of pathogenic IgG antibodies, thereby decreasing the autoimmune response. These treatments are crucial for MG patients as they help manage symptoms, improve muscle strength, and reduce the frequency of myasthenic crises, significantly enhancing the quality of life.

Update in immunosuppressive therapy of myasthenia gravis.