What is the mechanism of action of this treatment?

The most common treatments for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) often involve interleukin-6 (IL-6) receptor inhibitors like Satralizumab. These treatments work by blocking the IL-6 receptor, which is pivotal in the inflammatory cascade that characterizes MOGAD. By inhibiting this receptor, the treatments aim to reduce inflammation and prevent disease relapses. This mechanism is crucial for MOGAD patients as it helps to minimize neurological damage caused by recurrent inflammatory episodes, thereby preserving neurological function and improving overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) include immunosuppressive and immunomodulatory therapies such as Satralizumab, which is an Interleukin-6 Receptor Inhibitor. Known side effects of Satralizumab and similar treatments can include injection site reactions, increased risk of infections, liver enzyme abnormalities, and gastrointestinal symptoms like nausea. Patients may also experience headaches and nasopharyngitis. It is important to monitor for these side effects and discuss them with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments exclusively for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD). However, treatments targeting similar mechanisms, such as Interleukin-6 Receptor Inhibitors, are being studied. Satralizumab, an Interleukin-6 Receptor Inhibitor, is currently under investigation for its efficacy in treating MOGAD. This class of drugs is also used in other autoimmune conditions, such as neuromyelitis optica spectrum disorder (NMOSD), where Satralizumab has received FDA approval.

What other types of research exist?

Promising novel alternatives to Satralizumab for MOGAD patients in 2024 may include other monoclonal antibodies targeting different immune pathways, such as Rituximab (a CD20 inhibitor), Eculizumab (a complement inhibitor), and Tocilizumab (another IL-6 receptor inhibitor). Additionally, therapies like Inebilizumab (a CD19 inhibitor) and novel small molecule inhibitors targeting specific immune cells or cytokines involved in MOGAD are also being explored.

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Monoclonal Antibodies

Satralizumab for MOG Antibody Disease (Meteoroid Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening

Participants who are aged >=12 years at the time of signing Informed Consent Form

Must not have

Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study

Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing satralizumab, a medication that helps prevent relapses in patients with MOGAD by reducing inflammation and stopping the immune system from attacking the nervous system.

Who is the study for?

This trial is for people aged 12 and older with confirmed MOGAD who've had at least one relapse in the past year or two in the last two years. Participants must not be pregnant, agree to use contraception, have a certain level of disability (EDSS score 0-6.5), and good vision (BCVA better than 20/800). They can't join if they have other antibodies, infections, hepatitis B/C, are pregnant/breastfeeding, recently vaccinated with live vaccines, severe allergies to biologics or need high doses of steroids.

What is being tested?

The study tests whether Satralizumab is more effective than a placebo in preventing relapses in patients with MOGAD. It measures the time until a participant has their first relapse after starting treatment during a double-blind period where neither doctors nor participants know who's getting Satralizumab or placebo.

What are the potential side effects?

Satralizumab may cause side effects such as potential allergic reactions due to it being a biological agent. The exact side effects aren't listed here but typically include symptoms related to immune system changes since it targets specific pathways involved in inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I am not on or am currently taking long-term immune system suppression medication for MOGAD.

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I am 12 years old or older.

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My disability level allows me to walk at least 100 meters without aid or rest.

Exclusion Criteria

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

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I don't have any other illness needing strong steroids for more than 3 weeks.

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My blood test shows I have AQP4 antibodies.

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I have not received a live vaccine in the last 6 weeks.

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I do not have any active infections.

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I do not have active or untreated latent tuberculosis.

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

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884

21%

Upper respiratory tract infection

18%

Nasopharyngitis

15%

Headache

13%

Urinary tract infection

13%

Alanine aminotransferase increased

13%

Anaemia

11%

Alopecia

11%

Hyperlipidaemia

11%

Vertigo

11%

Chest discomfort

11%

Complement factor decreased

11%

Conjunctivitis

10%

Lymphopenia

10%

Leukopenia

Arthralgia

Cough

Eczema

Conjunctival haemorrhage

Diarrhoea

Oral herpes

Oral candidiasis

Bradycardia

Hypertransaminasaemia

Retinal haemorrhage

Hypofibrinogenaemia

Left ventricle outflow tract obstruction

Blepharospasm

Conjunctival deposit

Dry eye

Glaucoma

Excoriation

Blood urine

Protein urine present

Dehydration

Amenorrhoea

Pharyngeal erythema

Acne

Intervertebral disc protrusion

Muscle spasticity

Blood alkaline phosphatase increased

Polycythaemia

Oedema peripheral

Bacteriuria

Pyelonephritis

Respiratory tract infection

Wound

Epistaxis

Musculoskeletal stiffness

Large intestine polyp

Pancreatitis acute

Feeling abnormal

Hepatic function abnormal

Arthropod sting

Feeling hot

Pelvic fracture

Osteoarthritis

Nephrolithiasis

Platelet count decreased

Cataract

Chills

Contusion

Serum ferritin decreased

Dyspepsia

Onychomycosis

Viral upper respiratory tract infection

Upper respiratory tract inflammation

Plicated tongue

Compression fracture

Urobilinogen urine increased

Neck pain

Malaise

Angina pectoris

Abdominal distension

Cellulitis

Enterocolitis infectious

Pneumonia

Joint injury

Weight increased

Myopathy toxic

Spinal osteoarthritis

Epilepsy

Lower limb fracture

Low density lipoprotein increased

Weight decreased

Iron deficiency

Erythema

Rash pruritic

Spinal pain

Intercostal neuralgia

Eye pruritus

Panic disorder

Hypertension

Flushing

Anxiety

Blood pressure increased

Thermal burn

Neutropenia

Muscle spasms

Hypercholesterolaemia

Myalgia

Blood fibrinogen increased

Bronchitis

Laryngitis

Fall

Ear discomfort

Sinusitis

Rhinorrhoea

Dental caries

Rib fracture

Dyslipidaemia

Blepharitis

Rash

Constipation

Gastritis

Oropharyngeal pain

Pain in extremity

Cystitis

Prothrombin time prolonged

Hypocomplementaemia

Blood fibrinogen decreased

Influenza

Dizziness

Lymphocyte percentage increased

Vomiting

Toothache

Forearm fracture

White blood cell count decreased

Hordeolum

Aspartate aminotransferase increased

Periodontitis

Haemorrhoids

Lymphocyte count decreased

Large intestine infection

Rhinitis

Back pain

White blood cell count increased

Abdominal pain upper

Insomnia

Neuromyelitis optica pseudo relapse

Lumbar spinal stenosis

Blood creatine phosphokinase increased

Tonsillitis

Pharyngitis

Urticaria

Neutrophil count increased

Haemoglobin decreased

Upper limb fracture

Cervical dysplasia

Parkinsonism

Gait disturbance

Neutrophil percentage increased

Spinal compression fracture

Neutrophil count decreased

Non-cardiac chest pain

Hepatitis E

Iron deficiency anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment Open Label Period

Satralizumab Open-Label Period

Satralizumab + Baseline Treatment Double Blind Period

Placebo + Baseline Treatment Double Blind Period

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: Group A: SatralizumabExperimental Treatment1 Intervention

In the double-blind treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Group II: Group B: PlaceboPlacebo Group1 Intervention

In the double-blind treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Satralizumab

2014

Completed Phase 3

~370

0 / 8Eligibility 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 (MOGAD) often involve interleukin-6 (IL-6) receptor inhibitors like Satralizumab. These treatments work by blocking the IL-6 receptor, which is pivotal in the inflammatory cascade that characterizes MOGAD. By inhibiting this receptor, the treatments aim to reduce inflammation and prevent disease relapses. This mechanism is crucial for MOGAD patients as it helps to minimize neurological damage caused by recurrent inflammatory episodes, thereby preserving neurological function and improving overall quality of life.

Future research directions in multiple sclerosis therapies.