At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 167 enrolled
Drug / intervention
ARGX-113 +1 morebiological
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 Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, 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 and Placebo for Generalized Myasthenia Gravis. Completed, enrolled 167 participants across 66 sites in 16 countries.
Detailed Summary
A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.
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 Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartAug 2018
First PostedSep 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedSep 13, 2018
Enrollment StartAug 22, 2018
Primary CompletionApr 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.8 years ago
Interventions
ARGX-113biological
Intravenous administration of ARGX-113
Placebobiological
Intravenous administration of placebo