RecruitingPhase 2NCT06453694

Efgartigimod for the Treatment of Acute Optic Neuritis

A Pilot Randomized Trial of Efgartigimod Alfa for the Treatment of Incident Moderate to Severe Acute Optic Neuritis

Sponsor

Anastasia Vishnevetsky, MD, MPH

Enrollment

20 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Optic Neuritis

Summary

The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis (optic nerve inflammation). The main questions it aims to answer are: * Is it feasible to use efgartigimod alfa for optic neuritis? * Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis? * Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns? Participants will: * have their vision and blood tested * be asked questions about their vision * will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not * will have periodic visits over 6 months

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called efgartigimod in adults with a first episode of acute optic neuritis — sudden inflammation of the optic nerve causing vision loss, often linked to multiple sclerosis or related conditions. The drug works by reducing the harmful antibodies driving the inflammation. **You may be eligible if...** - You are 18 or older and experiencing your first episode of optic neuritis - You have vision loss that started within the past 10 days - Your vision in the affected eye is 20/60 or worse on an eye chart - Your optic nerve inflammation is confirmed by MRI **You may NOT be eligible if...** - You have had a previous episode of optic neuritis - You are pregnant or planning to become pregnant - You have certain immune system conditions that would conflict with the study drug - Your vision loss started more than 10 days ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEfgartigimod Alfa

2,016 mg will be administered subcutaneously by a healthcare provider on Day 0 and Day 3 of the trial. Rescue therapy with therapeutic plasma exchange will be given to any participant based on the results of Day 7 evaluation.

DRUGPlacebo

Subcutaneous injection of placebo will be administered by a healthcare provider on Day 0 and Day 3 of the trial. Rescue therapy with therapeutic plasma exchange will be given to any participant based on the results of Day 7 evaluation.

Locations(2)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06453694

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