drugset / Trial / NCT06453694

Efgartigimod for the Treatment of Acute Optic Neuritis

NCT06453694

Phase 2 Recruiting 20 enrolled Anastasia Vishnevetsky, MD, MPH argenx · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2025-08-12
Primary completion
2026-12
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Efgartigimod Alfa Protein / enzyme biologic 2016 mg Subcutaneous

Indications