drugset / Trial / NCT06453694
Efgartigimod for the Treatment of Acute Optic Neuritis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efgartigimod Alfa | Protein / enzyme biologic | 2016 mg | Subcutaneous |