At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
ARGX-113biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating ARGX-113 for Generalized Myasthenia Gravis. Completed, enrolled 151 participants across 52 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesBelgium, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Serbia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMar 2019
Primary CompletionJun 2022
Study CompletionJun 2022
TodayJul 2026
First PostedDec 10, 2018
Enrollment StartMar 1, 2019
Primary CompletionJun 23, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.6 years ago
Interventions
ARGX-113biological
Intravenous administration of ARGX-113