What side effects are associated with this type of intervention?

Common treatments for autoimmune encephalitis, particularly those involving monoclonal antibodies like Rozanolixizumab, often include medications such as rituximab and intravenous immunoglobulins (IVIg). Known side effects of these treatments can include infusion reactions, increased risk of infections, and potential allergic reactions. Rituximab specifically may cause side effects such as fever, chills, and low blood pressure during infusions, as well as longer-term risks like neutropenia and reactivation of viral infections. IVIg can lead to headaches, migraines, and, in rare cases, kidney dysfunction or thrombotic events.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of Autoimmune Encephalitis that are similar to Rozanolixizumab. However, monoclonal antibodies targeting immune components, such as rituximab (which targets CD20 on B cells), have been used off-label for various autoimmune conditions, including some forms of autoimmune encephalitis. These treatments aim to reduce the levels of pathogenic antibodies or modulate the immune response, similar to the mechanism of action of Rozanolixizumab.

What other types of research exist?

Promising novel alternatives to Rozanolixizumab for Autoimmune Encephalitis patients include Rituximab, a monoclonal antibody targeting CD20 on B cells, and Masitinib, a tyrosine kinase inhibitor that modulates neuroinflammation. Both have shown efficacy in related autoimmune and neuroinflammatory conditions.

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Monoclonal Antibodies

Rozanolixizumab for Autoimmune Encephalitis

Phase 2

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

Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1) antibody

Study participant has initiated or re-initiated corticosteroids at a dose of 500 to 1000 mg MP equivalent/day within 42 days prior to randomization

Must not have

Study participant has undergone a splenectomy

Study participant has received a live vaccination within 4 weeks prior to the Baseline Visit or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of investigational medicinal product (IMP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until the end of study visit (week 32)

Summary

This trial is testing rozanolixizumab, a medication that may help people with seizures by calming their immune system. It focuses on those who do not respond well to other treatments.

Who is the study for?

Adults aged 18-89 with LGI1 autoimmune encephalitis, weighing at least 35 kg, not pregnant or breastfeeding and using contraception can join. They must have frequent seizures or those controlled by high-dose steroids, and started treatment recently. Excluded are those with chronic infections, liver disease, positive TB test, organ transplants, hypersensitivity to study drugs or similar medications, recent live vaccinations, certain blood disorders or a history of cancer within the last five years.

What is being tested?

The trial is testing Rozanolixizumab's effectiveness in reducing seizures and improving cognitive function compared to a placebo. Participants will be randomly assigned to receive either the medication or placebo while monitoring seizure frequency and cognitive changes as well as safety and drug levels in the body.

What are the potential side effects?

Potential side effects of Rozanolixizumab may include reactions related to immune system suppression such as increased risk of infection. Specific side effects are not listed but would typically relate to how the drug affects the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I have tested positive for the LGI1 antibody.

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I started or restarted corticosteroids at a specific dose within the last 42 days.

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I have more than 2 seizures a week or they stopped with high dose steroids.

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I weigh at least 35 kg.

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I am not pregnant, not breastfeeding, and will follow contraceptive advice.

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I am between 18 and 89 years old.

Exclusion Criteria

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

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I have had my spleen removed.

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I have not received a live vaccine in the last 4 weeks and do not plan to during or within 8 weeks after the study.

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I am allergic to the study medication or similar drugs.

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I do not have any serious infections right now.

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I have had cancer or am currently battling cancer.

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I have had a solid organ or bone marrow transplant.

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My liver condition is currently unstable.

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My kidney function is low, with a GFR under 30.

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I have previously been treated with rozanolixizumab.

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I have epilepsy or new seizures not caused by LGI1 autoimmune encephalitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until the end of study visit (week 32)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until the end of study visit (week 32)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until the end of study visit (week 32) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of seizure free study participants at the end of the Treatment Period

Secondary study objectives

Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment Period

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Proportion of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment Period

+2 more

Side effects data

From 2021 Phase 3 trial • 71 Patients • NCT04124965

30%

Headache

12%

Blood immunoglobulin G decreased

12%

Diarrhoea

10%

Urinary tract infection

Nausea

Pyrexia

Myasthenia gravis

Hypertension

Back pain

Nasopharyngitis

Abdominal pain

Hypogammaglobulinaemia

Muscular weakness

Retinal detachment

Cardiac failure congestive

Biopsy kidney abnormal

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Rozanolixizumab ~7 mg/kg

Rozanolixizumab ~10 mg/kg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RozanolixizumabExperimental Treatment1 Intervention

Participants will be randomized to receive a predefined dose of rozanolixizumab.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive a dose of placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rozanolixizumab

2023

Completed Phase 3

~620

0 / 16Eligibility 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

Rozanolixizumab works by targeting the neonatal Fc receptor (FcRn), which is responsible for recycling IgG antibodies, thereby reducing the levels of pathogenic IgG in the body. This is crucial for autoimmune encephalitis patients as it helps decrease the autoimmune attack on the brain. Other common treatments include intravenous immunoglobulin (IVIg), which provides a large pool of antibodies that can neutralize pathogenic autoantibodies, and plasmapheresis, which physically removes antibodies from the blood. Corticosteroids are also used to reduce inflammation and suppress the immune response. These treatments are essential for managing autoimmune encephalitis as they help to control the immune system's attack on the brain, thereby reducing symptoms and preventing further neurological damage.