What side effects are associated with this type of intervention?

Common treatments for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD) include therapies like Rozanolixizumab and Rituximab. Rozanolixizumab, which inhibits the neonatal Fc receptor (FcRn) to reduce pathogenic IgG antibodies, is being studied for its efficacy and safety. Rituximab, another common treatment, targets CD-20 antigens. Known side effects of Rituximab include infusion reactions, serum-sickness-like reactions, and interstitial lung disease. Additionally, there is a risk of progressive multifocal leukoencephalopathy (PML) in some cases. Patients may also experience mild to moderate adverse reactions such as fatigue, headache, and nausea.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD). However, treatments targeting similar mechanisms, such as the inhibition of the neonatal Fc receptor (FcRn) to reduce pathogenic IgG antibodies, are being explored. Rozanolixizumab is one such investigational drug currently under study for its efficacy and safety in treating MOG-AD. Other treatments for related autoimmune conditions often involve immunosuppressive therapies and monoclonal antibodies, but specific FDA approvals for MOG-AD are still pending.

What other types of research exist?

Promising novel alternatives to Rozanolixizumab for MOG-AD patients in 2024 may include other FcRn inhibitors such as Efgartigimod and Nipocalimab, as well as B-cell depleting therapies like Rituximab and Ocrelizumab. These treatments aim to reduce pathogenic antibodies or modulate the immune response, similar to Rozanolixizumab.

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Monoclonal Antibodies

Rozanolixizumab for MOG-AD (cosMOG Trial)

Phase 3

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

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

Must have

Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent

Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD

Must not have

Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator

Participant has a current or medical history of primary immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called rozanolixizumab to see if it can safely and effectively treat adults with a nervous system condition called MOG-AD. The medication aims to reduce harmful antibodies that cause the disease.

Who is the study for?

This trial is for adults aged 18-89 with a confirmed diagnosis of MOG-AD, who have had at least one relapse in the past year and tested positive for MOG antibodies recently. They must be stable health-wise and not have other autoimmune diseases or primary immunodeficiency.

What is being tested?

The study tests Rozanolixizumab's effectiveness and safety against a placebo in treating MOG-AD. Participants will randomly receive either the actual drug or a placebo to compare outcomes.

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include infusion-related discomfort, potential immune system changes, allergic reactions, or general medication intolerance.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 89 years old.

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I have been diagnosed with MOG Antibody Disease.

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I have had at least one MOG-AD relapse in the past year and a positive MOG antibody test.

Exclusion Criteria

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

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I do not have any serious ongoing infections.

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I have a history of primary immunodeficiency.

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I tested positive for aquaporin-4 antibodies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period

For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period

For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period

Secondary study objectives

For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit

For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)

For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB 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

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: Rozanolixizumab ArmExperimental Treatment1 Intervention

Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.

Group II: Placebo ArmPlacebo Group1 Intervention

Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rozanolixizumab

2023

Completed Phase 3

~620

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 Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD) focus on reducing the levels of pathogenic IgG antibodies that target the myelin sheath. Rozanolixizumab, for example, inhibits the neonatal Fc receptor (FcRn), which is responsible for recycling IgG antibodies, thereby lowering their levels in the bloodstream. This reduction in pathogenic IgG antibodies is crucial for MOG-AD patients as it helps to decrease inflammation and prevent further damage to the myelin sheath, potentially improving neurological outcomes and reducing relapses.

Fcγ receptor IIIA genotype is associated with rituximab response in antimyelin-associated glycoprotein neuropathy.