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Efgartigimod for the Treatment of Acute Optic Neuritis

NCT06453694 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-10

No results posted yet for this study

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

Conditions

Interventions

DRUG

Efgartigimod 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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • argenx

    collaborator INDUSTRY

  • Anastasia Vishnevetsky, MD, MPH

    lead OTHER

Principal Investigators

  • Anastasia Vishnevetsky, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-12-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453694 on ClinicalTrials.gov