A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511796-15-00

Acronym

ARGX-113-2308

Enrollment

167

Registered

2024-10-01

Start date

2024-10-16

Completion date

Unknown

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Brief summary

MG-ADL total score change from baseline to day 29 in part A

Detailed description

• QMG total score change from baseline to day 29 in part A, • Proportion of participants who are both MG-ADL and QMG responders in part A

Interventions

DRUGPlacebo efgartigimod IV concentrate for solution

DRUGARGX-113

DRUGVyvgart 20 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MG-ADL total score change from baseline to day 29 in part A	—

Secondary

Measure	Time frame
• QMG total score change from baseline to day 29 in part A, • Proportion of participants who are both MG-ADL and QMG responders in part A	—

Countries

Belgium, Cyprus, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Netherlands, Norway, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026