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Monoclonal Antibodies

Efgartigimod for Optic Neuritis (PET-AON Trial)

Phase 2
Waitlist Available
Research Sponsored by Anastasia Vishnevetsky, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with a first episode of optic neuritis, based on clinical presentation and confirmed by contrast enhancement or T2 hyperintensity of the optic nerve on MRI brain or orbits using a 1.5 Tesla (T) MRI scanner or greater
Onset of optic neuritis-related vision changes within 10 days of enrollment
Must not have
Clinically significant recent major surgery
Contraindication to MRI or plasma exchange
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 2 years

Summary

This trial is testing a new drug called efgartigimod alfa against a placebo in adults with optic nerve inflammation. It aims to see if efgartigimod alfa is

Who is the study for?
This trial is for adults experiencing their first episode of optic neuritis, which is inflammation of the optic nerve. Participants must be willing to undergo vision and blood tests, answer questions about their vision, receive standard steroid treatment, and attend periodic visits over a six-month period.
What is being tested?
The study is testing efgartigimod alfa against a placebo in treating acute optic neuritis. It aims to determine if efgartigimod alfa can be feasibly used for this condition and whether it's more effective than a placebo in restoring vision quickly and significantly.
What are the potential side effects?
Specific side effects are not listed here; however, participants may experience side effects related to efgartigimod alfa or the standard steroid treatment they will receive during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with optic neuritis for the first time.
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My vision changed due to optic neuritis less than 10 days ago.
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My vision in my worse eye is 20/60 or poorer, even with the best possible correction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a major surgery recently.
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I cannot undergo MRI or plasma exchange due to health reasons.
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I have HIV or a common variable immunodeficiency.
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I had cancer before but have been free of it for over a year.
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I do not have any serious ongoing infections.
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I was diagnosed with a CNS demyelinating disease before my current episode.
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I had vision problems in one eye before my optic neuritis started.
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I have been diagnosed with optic neuropathy before my current eye nerve inflammation.
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I have been treated with high-dose steroids for optic neuritis for more than 3 days.
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I have a condition other than MS, NMOSD, or MOGAD that could be causing my optic neuritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in high contrast visual acuity for effect size and standard deviation estimation
Change in low contrast visual acuity for effect size and standard deviation estimation
Recruitment Rate
+1 more
Secondary study objectives
Color Vision
Contrast sensitivity
Difference in change in low contrast visual acuity from baseline to 6 months between groups
+15 more
Other study objectives
Contrast enhancement
Ganglion cell layer (GCL) thickness at 1 month between groups
Ganglion cell layer (GCL) thickness at 3 months between groups
+9 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Efgartigmod alfaActive Control1 Intervention
10 patients will receive efgartigimod alfa All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks.
Group II: PlaceboPlacebo Group1 Intervention
10 patients will receive placebo. All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks.

Find a Location

Who is running the clinical trial?

Anastasia Vishnevetsky, MD, MPHLead Sponsor
argenxIndustry Sponsor
68 Previous Clinical Trials
10,380 Total Patients Enrolled
~13 spots leftby Dec 2026
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