Vyvgart 20 mg/mL concentrate for solution for infusion
Sponsors
Argenx, Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Conditions
Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia GravisGeneralized Myasthenia GravisGeneralized Myasthenia Gravis (gMG)Patients affected by generalized myasthenia gravisPrimary Immune thrombocytopenia (ITP)
Phase 2
A Long-term, Single-Arm, Open-label, Multicenter Trial to Evaluate Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
RecruitingCTIS2023-507379-23-00
Start: 2022-08-18Target: 19Updated: 2025-12-03
Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
RecruitingCTIS2024-513854-31-00
Start: 2021-10-27Target: 12Updated: 2025-11-11
Phase 3
ARGX-113-2003: A Phase 3B, Randomized, Open-Label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis
CompletedCTIS2024-510932-36-00
Start: 2021-12-21End: 2025-10-06Target: 42Updated: 2025-10-15
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
Active, not recruitingCTIS2024-511796-15-00
Start: 2024-10-16Target: 167Updated: 2025-10-07
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
RecruitingCTIS2024-515451-38-00
Start: 2025-02-27Target: 52Updated: 2026-01-23