Clinical trials: Efgartigimod
Generalized Myasthenia Gravis, gMG
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.
- Trial name
- ADAPT Jr + (NCT05374590)
- Testing
- Efgartigimod IV or Efgartigimod PH20 SC
- Where
- 16 sites in United States, Belgium and 8 more
- Volunteers
- 12 people
- Sponsor
- argenx
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
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG.
- Trial name
- ADAPT Jr (NCT04833894)
- Testing
- Efgartigimod IV
- Where
- 25 sites in United States, Austria and 10 more
- Volunteers
- 15 people
- Sponsor
- argenx
IgG4-related Disease
A Study of Efgartigimod in Patients With IgG4-Related Disease
The goal of this clinical trial is to learn if efgartigimod can treat IgG4-related disease in adults. The main questions it aims to answer are: In patients with IgG4-related disease, does treatment with efgartigimod reduce the…
- Trial name
- NCT07025330
- Testing
- Efgartigimod
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Stanford University
Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.
- Trial name
- POTS (NCT05918978)
- Testing
- Efgartigimod
- Where
- 9 sites in United States
- Volunteers
- 33 people
- 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
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
- Trial name
- ADHERE+ (NCT04280718)
- Testing
- Efgartigimod PH20 SC
- Where
- 147 sites in United States, Austria and 22 more
- Volunteers
- 229 people
- Sponsor
- argenx
Active Idiopathic Inflammatory Myopathy, Myositis
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
- Conditions
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA (NCT05523167)
- Testing
- EFG PH20 SC, PBO
- Where
- 202 sites in United States, Argentina and 34 more
- Volunteers
- 265 people
- Sponsor
- argenx
Neuromyelitis Optica, Efgartigimod
Efgartigimod in Acute Neuromyelitis Optica Spectrum Disorders
This study aims to retrospective investigate the safety and effectiveness of Efgartigimod in the acute phase of neuromyelitis optica spectrum disorders (NMOSD) patients.
- Trial name
- NCT06118398
- Testing
- Intravenous methylprednisolone (IVMP) and Efgartigimod, IVMP
- Volunteers
- 24 people
- Sponsor
- Feng Jinzhou
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
Generalized Myasthenia Gravis
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the…
- Trial name
- ADAPTSC+ (NCT04818671)
- Testing
- efgartigimod PH20 SC
- Where
- 47 sites in United States, Belgium and 10 more
- Volunteers
- 184 people
- Sponsor
- argenx
Graves' Disease, Graves Disease
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated.
- Trial name
- VitaliThy (NCT07570316)
- Testing
- Efgartigimod PH20 SC
- Where
- 32 sites in United States, Georgia
- Volunteers
- 230 people
- Sponsor
- argenx
Guillain-Barre Syndrome
Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome
The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS).
- Trial name
- NCT05701189
- Testing
- Efgartigimod Alfa-Fcab, Intravenous Immunoglobulin (IVIg)
- Where
- United States
- Sponsor
- Chafic Karam
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
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
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
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
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
Primary Immune Thrombocytopenia
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
- Trial name
- ADVANCE (NCT04188379)
- Testing
- efgartigimod
- Where
- 121 sites in United States, Austria and 16 more
- Volunteers
- 131 people
- Sponsor
- argenx