NCT03770403

A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-113	Intravenous administration of ARGX-113

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-06-23
• Completion: 2022-06-30
• First posted: 2018-12-10
• Last updated: 2023-07-14
• Results posted: 2023-07-14

Locations

52 sites across 15 countries: United States, Belgium, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Serbia

Regulatory

• FDA-regulated drug study