Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06453694
Brief 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
Detailed Description:
This study is designed as a pilot, single-site, randomized, placebo-controlled, 2-arm, parallel-group clinical trial comparing efgartigimod alfa in addition to standard of care (IV steroids with a standardized oral taper) to standard of care with placebo, with an option for rescue therapy with plasma exchange for all participants in the case of poor therapeutic response.
Study:
NCT06453694
Study Brief:
Protocol Section:
NCT06453694