Clinical trials: sponsored by argenx
Myasthenia Gravis, MG
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
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
- Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis
- Trial name
- NCT07294170
- Testing
- Efgartigimod IV, Empasiprubart IV, Efgartigimod PH20 SC PFS
- Where
- 37 sites in United States, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP
Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the "treatment journey" of participants with CIDP, and…
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
- Trial name
- NCT07264426
- Testing
- Efgartigimod PH20 SC
- Where
- 23 sites in United States, Germany
- Volunteers
- 200 people
- Sponsor
- argenx
Myasthaenia Gravis
Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
This study is an open label, single center, prospective, 26 weeks study with descriptive analysis where IVIG is replaced by efgartigimod therapy. MG-ADL and MGQOL evaluations will occur weekly throughout the study to week 26.
- Trial name
- NCT06765161
- Testing
- efgartigimod administration
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Clinique Neuro-Outaouais
Congenital Myasthenic Syndrome, CMS
A Study to Assess Efficacy and Safety of Adimanebart in Adult and Pediatric Participants With DOK7-,MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes (CMS)
The purpose of this study is to assess efficacy and safety of adimanebart in participants at least 12 years of age with DOK7-, MUSK-, AGRN-, or LRP4- Congenital Myasthenic Syndromes (CMS).
- Trial name
- CoMetS (NCT07746089)
- Testing
- Adimanebart IV
- Volunteers
- 105 people
- 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
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 (NCT07596849)
- Testing
- efgartigimod PH20 SC
- Where
- 42 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 230 people
- Sponsor
- argenx
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG)
ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
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), MG - Myasthenia Gravis, gMG
- Trial name
- ADAPT Forward2 (NCT07673627)
- Testing
- Empasiprubart IV, Efgartigimod PH20 SC PFS
- Where
- 8 sites in United States, Greece and 1 more
- Volunteers
- 40 people
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Trial name
- emnergize (NCT07091630)
- Testing
- Empasiprubart IV
- Where
- 89 sites in United States, Argentina and 23 more
- Volunteers
- 160 people
- Sponsor
- argenx
Immunoglobulin A Nephropathy (IgAN)
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.
- Trial name
- Verdant (NCT07773727)
- Testing
- ARGX-121
- Where
- 6 sites in United States, Japan
- Volunteers
- 120 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
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
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
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
- Trial name
- emvigorate (NCT06920004)
- Testing
- empasiprubart, IVIg
- Where
- 102 sites in United States, Argentina and 29 more
- Volunteers
- 218 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
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
Guillain-Barré Syndrome (GBS)
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
The main purpose of this study is to learn whether empasiprubart, when given in addition to intravenous immunoglobulin (IVIg), helps adults with Guillain-Barré syndrome (GBS) recover and whether it is safe.
- Trial name
- embridge (NCT07821762)
- Testing
- Empasiprubart IV, Intravenous immunoglobulin (IVIg)
- Volunteers
- 63 people
- Sponsor
- argenx
Congenital Myasthenic Syndrome
A Natural History Study in Participants With Congenital Myasthenic Syndromes (CMS) Due to Mutations in DOK7, MUSK, AGRN, or LRP4
Participants will attend up to 4 study visits to collect clinical assessments. The assessments will evaluate participants' symptoms and quality of life to understand disease activity in patients with CMS due to mutations in DOK7…
- Trial name
- NCT06078553
- Where
- 33 sites in United States, Austria and 10 more
- Volunteers
- 100 people
- Sponsor
- argenx