Clinical trials: sponsored by 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
Systemic Sclerosis (SSc)
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis.
- Trial name
- eSScape (NCT06655155)
- Testing
- Efgartigimod PH20 SC
- Where
- 79 sites in United States, Argentina and 22 more
- Volunteers
- 87 people
- Sponsor
- argenx
Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP).
- Conditions
- Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia, ITP, Immune Thrombocytopenic Purpura
- Trial name
- Advance Jr (NCT07194850)
- Testing
- Efgartigimod IV
- Where
- 26 sites in France, Germany and 8 more
- Volunteers
- 24 people
- Sponsor
- argenx
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Delayed Graft Function
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function.
- Trial name
- VARVARA (NCT05907096)
- Testing
- ARGX-117
- Where
- 45 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- argenx
Spinal Muscular Atrophy (SMA)
A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy
This study aims to find the correct dose of ARGX-119 for children with SMA. The study will also look at how safe the study drug is, how well it works, how it moves through the body, and how the immune system responds to it.
- Trial name
- Sparkle (NCT07287982)
- Testing
- ARGX-119 IV
- Where
- 28 sites in United States, Australia and 2 more
- Volunteers
- 60 people
- Sponsor
- argenx
Generalized Myasthenia Gravis
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years.
- Trial name
- ADAPT Jr SC (NCT06392386)
- Testing
- Efgartigimod PH20 SC
- Where
- 22 sites in United States, Australia and 12 more
- Volunteers
- 12 people
- Sponsor
- argenx
Multifocal Motor Neuropathy (MMN)
A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
The main purpose of the study is to evaluate empasiprubart use in adults living with Multifocal Motor Neuropathy (MMN). The researchers will evaluate the effect of empasiprubart on the thickness of the nerves, muscle strength…
- Trial name
- EmpaSound (NCT07610564)
- Testing
- Empasiprubart IV
- Where
- 4 sites in Georgia
- Volunteers
- 60 people
- Sponsor
- argenx
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis
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
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
- Trial name
- NCT07284420
- Testing
- Efgartigimod IV, Empasiprubart IV
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- argenx
Multifocal Motor Neuropathy (MMN), MMN
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart).
- Trial name
- Empassion (NCT06742190)
- Testing
- Empasiprubart, IVIG (Intravenous Immunoglobulin)
- Where
- 109 sites in United States, Australia and 24 more
- Volunteers
- 154 people
- Sponsor
- argenx
Autoimmune Encephalitis (AE)
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE).
- Trial name
- Polaris (NCT07583641)
- Testing
- Efgartigimod PH20 (ARGX-113) SC
- Where
- 2 sites in United States
- Volunteers
- 170 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
Amyotrophic Lateral Sclerosis
A Safety and Efficacy Study of ARGX-119 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
This study aims to evaluate the safety of ARGX-119 in adults with ALS. The study will also assess the impact of ARGX-119 on ALS disease outcomes, including muscle function.
- Trial name
- ReALiSe (NCT06441682)
- Testing
- ARGX-119
- Where
- 9 sites in Belgium, Canada and 4 more
- Volunteers
- 60 people
- Sponsor
- argenx
Sjogrens Disease, Primary Sjögren's Syndrome Painful Sensory Neuropathies
A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)
This study aims to assess the efficacy and safety of efgartigimod PH20 in adults with Sjogren's Disease (SjD) associated with nerve damage.
- Trial name
- SERENITY (NCT07760818)
- Testing
- efgartigimod PH20 SC
- Volunteers
- 75 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
Congenital Myasthenic Syndrome, CMS
A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)
The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes.
- Trial name
- NCT06436742
- Testing
- ARGX-119
- Where
- 9 sites in United States, Canada and 4 more
- Volunteers
- 15 people
- Sponsor
- argenx
Myasthenia Gravis, Ocular
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis.
- Trial name
- ADAPT oculus (NCT06558279)
- Testing
- Efgartigimod PH20 SC
- Where
- 102 sites in United States, Australia and 23 more
- Volunteers
- 141 people
- Sponsor
- argenx
Antibody-mediated Rejection
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.
- Trial name
- Shamrock (NCT06503731)
- Testing
- Efgartigimod PH20 SC - prefilled syringe
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 33 people
- Sponsor
- argenx
Healthy Volunteers (HV), Healthy Volunteer
A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body.
- Trial name
- NCT07673601
- Testing
- Adimanebart IV, Adimanebart SC - formulation A, Adimanebart SC - formulation B
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Trial name
- emlight (NCT07638566)
- Testing
- Empasiprubart IV
- Volunteers
- 6 people
- Sponsor
- argenx