Efgartigimod IV

BIOLOGICAL12 trials

Sponsors

argenx

Conditions

AChR-Ab Seropositive Generalized Myasthenia GravisGeneralized Myasthenia GravisGeneralized Myasthenia Gravis (gMG)Healthy VolunteersITPITP - Immune ThrombocytopeniaIdiopathic Thrombocytopenic PurpuraIdiopathic Thrombocytopenic Purpura (ITP)

Phase 1

A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

CompletedNCT04564066

argenxHealthy Volunteers

Start: 2020-08-18End: 2021-02-11Updated: 2021-04-05

A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

CompletedNCT05927415

argenxRenal Impairment

Start: 2023-07-17End: 2024-06-12Updated: 2024-06-26

Phase 2

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

RecruitingNCT04833894

argenxGeneralized Myasthenia Gravis

Start: 2021-10-26End: 2027-03-01Target: 12Updated: 2026-02-18

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)

TerminatedNCT05810961

argenxMembranous Nephropathy

Start: 2023-02-20End: 2024-08-05Updated: 2024-11-22

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

CompletedNCT05810948

argenxLupus Nephritis

Start: 2023-02-21End: 2025-09-01Updated: 2025-12-18

A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)

RecruitingNCT07194850

argenxIdiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura (ITP), Immune Thrombocytopenia (ITP) +4

Start: 2025-10-20End: 2030-10-01Target: 24Updated: 2026-08-12

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

RecruitingNCT07284420

argenxAChR-Ab Seropositive Generalized Myasthenia Gravis, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG) +3

Start: 2025-12-19End: 2028-03-07Target: 70Updated: 2026-09-18

Phase 3

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

CompletedNCT04735432

argenxGeneralized Myasthenia Gravis

Start: 2021-02-05End: 2021-12-13Updated: 2023-02-28

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

CompletedNCT04980495

argenxGeneralized Myasthenia Gravis, gMG, MG - Myasthenia Gravis

Start: 2021-12-16End: 2025-10-06Updated: 2026-05-27

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Active, not recruitingNCT06298552

argenxGeneralized Myasthenia Gravis, gMG, Myasthenia Gravis +1

Start: 2024-04-16End: 2028-06-01Updated: 2026-08-10

A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

RecruitingNCT06544499

argenxPrimary Immune Thrombocytopenia (ITP)

Start: 2024-10-18End: 2028-06-01Target: 69Updated: 2026-05-01

Unknown Phase

ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

RecruitingNCT07294170

argenxAChR-Ab Seropositive Generalized Myasthenia Gravis, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG) +3

Start: 2025-12-19End: 2028-03-07Target: 70Updated: 2026-09-18

Related Papers

Schémas posologiques à cycles fixes et toutes les 2 semaines (Q2W) d’efgartigimod intraveineux dans la myasthénie auto-immune généralisée : partie B de l’essai de phase 3b ADAPT NXT

Revue Neurologique2026-03-24

Sustained improvements in patient-reported outcomes after intravenous efgartigimod in adults with primary immune thrombocytopenia in a Phase 3 clinical trial (ADVANCE IV) and the first 52 weeks in its open-label extension study (ADVANCE IV+)

Blood2025-11-03

Subcutaneous efgartigimod PH20 in generalized myasthenia gravis: A phase 3 randomized noninferiority study (ADAPT-SC) and interim analyses of a long-term open-label extension study (ADAPT-SC+)

Neurotherapeutics2024-09-0133 citations