NCT06558279

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

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis, Ocular

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Efgartigimod PH20 SC	Subcutaneous efgartigimod PH20 SC given by prefilled syringe
OTHER	Placebo PH20 SC	Subcutaneous placebo PH20 SC given by prefilled syringe

Timeline

• Start date: 2024-09-18
• Primary completion: 2026-01-01
• Completion: 2027-12-01
• First posted: 2024-08-16
• Last updated: 2025-12-15

Locations

102 sites across 25 countries: United States, Australia, Austria, Belgium, Canada, China, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Italy, Japan, Netherlands, Poland, Portugal, Serbia, South Korea, Spain, Sweden, United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study