Clinical trials: Efgartigimod
Bioequivalence
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe…
- Trial name
- NCT05817435
- Testing
- efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- argenx
Primary Immune Thrombocytopenia
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- ADVANCE SC+ (NCT04812925)
- Testing
- efgartigimod PH20 SC
- Where
- 83 sites in United States, Argentina and 23 more
- Volunteers
- 173 people
- Sponsor
- argenx
NMOSD
Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder
This study aims to evaluate the efficacy and safety of different monoclonal antibody in the acute phase of neuromyelitis optica spectrum disorder (MAAP-NMO).
- Trial name
- NCT07182409
- Volunteers
- 40 people
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
Stiff Person Syndrome
VYVGART (Hytrulo) in Patients With Stiff Person Syndrome (SPS)
Stiff Person Syndrome (SPS) is a rare autoimmune disorder, characterized by: a) incapacitating diffuse muscle stiffness prominent in the axial, abdominal and thoracolumbar paraspinal muscles leading to hyperlordosis, difficulty…
- Trial name
- NCT07860021
- Testing
- VYVGART Hytrulo
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Thomas Jefferson University
Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy.
- Trial name
- NCT06299748
- Testing
- Efgartigimod
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 279 people
- Sponsor
- argenx
Myasthenia Gravis
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the…
- Trial name
- EPIC (NCT07217587)
- Testing
- Nipocalimab, Efgartigimod
- Where
- 19 sites in United States, Israel and 1 more
- Volunteers
- 115 people
- Sponsor
- Janssen Research & Development, LLC
Generalized Myasthenia Gravis (gMG), gMG
A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
This study aims to generate real world evidence (RWE) from Italian clinical practice on the impact of efgartigimod alfa in gMG patients encompassing clinical outcomes and patient reported experiences.
- Trial name
- POEMA (NCT07595653)
- Where
- 30 sites in Italy
- Volunteers
- 100 people
- Sponsor
- argenx
Primary Sjögren's Syndrome
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS).
- Trial name
- Rho plus (NCT06203457)
- Testing
- Efgartigimod
- Where
- 11 sites in Belgium, Hungary and 1 more
- Volunteers
- 24 people
- Sponsor
- argenx
Stiff-Person Syndrome
Efgartigimod for Stiff Person Syndrome (ESPS)
The goal of this clinical trial is to examine the proportion of patients with stiff person syndrome with no worsening in stiffness and/or spasms while on efgartigimod-hyaluronidase (EFD) when compared to their current treatment.
- Trial name
- ESPS (NCT06528392)
- Testing
- Efgartigimod
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of South Florida
Myositis, Active Idiopathic Inflammatory Myopathy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
- Conditions
- Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA+ (NCT05979441)
- Testing
- Efgartigimod PH20 SC
- Where
- 92 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- argenx
Generalized Myasthenia Gravis, MG - Myasthenia Gravis
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).
- Conditions
- Generalized Myasthenia Gravis, MG - Myasthenia Gravis, gMG
- Trial name
- ADAPT NXT (NCT04980495)
- Testing
- Efgartigimod IV
- Where
- 39 sites in United States, Austria and 9 more
- Volunteers
- 69 people
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CIDP
Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options.
- Trial name
- NCT04777734
- Testing
- Efgartigimod PH20 SC
- Sponsor
- argenx
Guillain-Barré Syndrome
Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome(GREAT)
The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS).
- Trial name
- GREAT (NCT07806916)
- Testing
- Intravenous immunoglobulin (IVIG), Efgartigimod Alfa-Fcab
- Volunteers
- 110 people
- Sponsor
- Beijing Tiantan Hospital
Efgartigimod, Intravenous Immunoglobulin
EFG vs IVIG in TAMG
This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor…
- Conditions
- Efgartigimod, Intravenous Immunoglobulin, Myasthenia Gravis Associated With Thymoma
- Trial name
- NCT07231523
- Testing
- Efgartigimod + Thymectomy, Intravenous immunglobulin + Thymectomy
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shanghai Zhongshan Hospital
Generalized Myasthenia Gravis
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20…
- Trial name
- ADAPTsc (NCT04735432)
- Testing
- efgartigimod PH20 SC, efgartigimod IV
- Where
- 47 sites in United States, Belgium and 9 more
- Volunteers
- 110 people
- Sponsor
- argenx
Healthy Volunteers
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
This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.
- Trial name
- NCT04564066
- Testing
- efgartigimod IV, efgartigimod PH20 SC
- Where
- Netherlands
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- argenx
Primary Immune Thrombocytopenia (ITP)
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP).
- Trial name
- advance NEXT (NCT06544499)
- Testing
- Efgartigimod IV
- Where
- 94 sites in United States, Austria and 15 more
- Volunteers
- 69 people
- Sponsor
- argenx
Generalized Myasthenia Gravis, gMG
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis…
- Conditions
- Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Generalized, Myasthenia Gravis
- Trial name
- ADAPT SERON (NCT06298552)
- Testing
- Efgartigimod IV
- Where
- 91 sites in United States, Belgium and 20 more
- Volunteers
- 119 people
- Sponsor
- argenx
Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG).
- Conditions
- Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations, AChR Myasthenia Gravis
- Trial name
- NCT06860633
- Testing
- Efgartigimod
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Lupus Nephritis
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN).
- Trial name
- NCT05810948
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 73 people
- Sponsor
- argenx