drugset / Trial / NCT06558279

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

NCT06558279

Phase 3 Active not recruiting 141 enrolled argenx
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.

Timeline

Start
2024-09-18
Primary completion
2026-01-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic Subcutaneous