What side effects are associated with this type of intervention?

Common treatments for Myasthenia Gravis include acetylcholinesterase inhibitors, corticosteroids, immunosuppressants, and monoclonal antibodies. Acetylcholinesterase inhibitors can cause gastrointestinal issues, muscle cramps, and increased salivation. Corticosteroids may lead to weight gain, hypertension, diabetes, and osteoporosis. Immunosuppressants like azathioprine and mycophenolate mofetil can cause liver toxicity, increased infection risk, and gastrointestinal disturbances. Monoclonal antibodies, such as rituximab, can result in infusion reactions, infections, and, rarely, progressive multifocal leukoencephalopathy. Treatments similar to Rozanolixizumab, which target the neonatal Fc receptor to reduce IgG antibodies, may have side effects including headaches, infections, and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Myasthenia Gravis, including monoclonal antibodies like eculizumab (Soliris), which inhibits the complement system, and rituximab, which targets CD20 on B cells. These treatments aim to reduce the autoimmune attack on the neuromuscular junction. While specific FDA approvals for drugs targeting the neonatal Fc receptor (similar to Rozanolixizumab) are not detailed, the focus on reducing pathogenic IgG antibodies is a promising approach in ongoing research.

What other types of research exist?

Promising novel alternatives to Rozanolixizumab for Myasthenia Gravis patients include Efgartigimod, a neonatal Fc receptor antagonist similar to Rozanolixizumab, and Rituximab, a monoclonal antibody targeting CD20 on B cells, which has shown efficacy in reducing autoantibody production. Additionally, complement inhibitors like Eculizumab, which targets the complement protein C5, offer another therapeutic approach by preventing the formation of the membrane attack complex involved in the pathogenesis of MG.

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Monoclonal Antibodies

Rozanolixizumab for Myasthenia Gravis

Phase 3

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years

Awards & highlights

Study Summary

This trial will test if an additional 6 weeks of treatment with rozanolixizumab is safe and effective for people with generalized myasthenia gravis.

Who is the study for?

This trial is for people with generalized myasthenia gravis (gMG) who weigh at least 35 kg. Participants must have completed a prior related study or needed rescue therapy during it, and cannot join if they've had severe reactions to similar medications, certain infections like TB, or are planning to receive live vaccines soon.Check my eligibility

What is being tested?

The trial is testing additional 6-week treatment cycles of Rozanolixizumab in patients with gMG. It aims to evaluate the safety and effectiveness of this medication over repeated doses.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions related to immune system modulation such as infusion-related responses, increased risk of infections due to immunosuppression, and possible hypersensitivity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from end of the 6-week treatment cycle (day 43) to the next 6-week treatment cycle (day 1), assessed up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)

Percentage of participants with treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar symptoms' score within one treatment cycle

Fatigue

Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within one treatment cycle

+6 more

Side effects data

From 2021 Phase 3 trial • 71 Patients • NCT04124965

29%

Headache

17%

Diarrhoea

12%

Blood immunoglobulin G decreased

12%

Nausea

10%

Vomiting

10%

Nasopharyngitis

10%

Rash

Back pain

Pyrexia

Abdominal pain

Urinary tract infection

Hypogammaglobulinaemia

Pericarditis

Myasthenia gravis

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Rozanolixizumab ~10 mg/kg

Rozanolixizumab ~7 mg/kg

Trial Design

2Treatment groups

Experimental Treatment

Group I: Rozanolixizumab dosage regimen 2Experimental Treatment1 Intervention

Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.

Group II: Rozanolixizumab dosage regimen 1Experimental Treatment1 Intervention

Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rozanolixizumab

2023

Completed Phase 3

~620

Do I qualify?Apply below to find out

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 immunosuppressive therapies and biological drugs that target the immune system. These treatments work by reducing the production or activity of autoantibodies that attack the acetylcholine receptors at the neuromuscular junction, leading to muscle weakness. For example, Rozanolixizumab inhibits the neonatal Fc receptor, which reduces the levels of pathogenic IgG antibodies. This is crucial for MG patients as it directly addresses the underlying autoimmune mechanism, potentially improving muscle strength and reducing symptoms. By targeting specific components of the immune system, these treatments offer a more precise approach to managing MG, which can lead to better outcomes and fewer side effects compared to broader immunosuppressive therapies.

Update in immunosuppressive therapy of myasthenia gravis.