Clinical trials: sponsored by argenx
Healthy Volunteers
A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants
This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe.
- Trial name
- NCT07612020
- Testing
- empasiprubart SC AI, empasiprubart IV
- Where
- Canada
- Volunteers
- 130 people, healthy volunteers welcome
- 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
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
Leukemia, Myeloid, Acute
Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).
- Trial name
- ELEVATE (NCT04150887)
- Testing
- Cusatuzumab, Azacitidine, Venetoclax
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 61 people
- Sponsor
- OncoVerity, Inc.
Multifocal Motor Neuropathy
A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously…
- Trial name
- ARDA (NCT05225675)
- Testing
- ARGX-117
- Where
- 40 sites in United States, Austria and 9 more
- Volunteers
- 54 people
- Sponsor
- argenx
Epidermolysis Bullosa (EB), Epidermolysis Bullosa Acquisita
Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)
The study objective is to see if IV Efgartigimod and Vyjuvek treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and IV Efgartigimod treatment in Epidermolysis Bullosa Acquisita (EBA) improves wound healing and affects…
- Conditions
- Epidermolysis Bullosa (EB), Epidermolysis Bullosa Acquisita, Recessive Dystrophic Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa
- Trial name
- NCT07011589
- Testing
- Efgartigimod
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- M. Peter Marinkovich
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
Healthy Volunteers
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body.
- Trial name
- NCT06968338
- Testing
- ARGX-213
- Where
- Canada
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- argenx
Primary Sjogrens Disease
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD).
- Trial name
- Unity (NCT06684847)
- Testing
- Efgartigimod PH20 SC
- Where
- 303 sites in United States, Argentina and 37 more
- Volunteers
- 631 people
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyneuropathy
A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC
This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
- Trial name
- NCT06637072
- Testing
- Efgartigimod PH20 SC
- Where
- 13 sites in United States
- Volunteers
- 23 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
Thyroid Eye Disease
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease
This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with…
- Trial name
- UplighTED (NCT06307613)
- Testing
- Efgartigimod PH20 SC
- Where
- 77 sites in United States, Australia and 14 more
- Volunteers
- 102 people
- Sponsor
- argenx
Thyroid Eye Disease
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.
This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with…
- Trial name
- UplighTED (NCT06307626)
- Testing
- Efgartigimod PH20 SC
- Where
- 76 sites in United States, Austria and 16 more
- Volunteers
- 105 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia
A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.
- Trial name
- ADVANCE+ (NCT04225156)
- Testing
- efgartigimod
- Where
- 87 sites in United States, Austria and 16 more
- Volunteers
- 101 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
Multifocal Motor Neuropathy (MMN)
A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and…
- Trial name
- ARDA+ (NCT05405361)
- Testing
- ARGX-117
- Where
- 27 sites in United States, Austria and 9 more
- Volunteers
- 51 people
- Sponsor
- argenx
New Onset Generalized Myasthenia Gravis (gMG)
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC.
- Trial name
- ADAPT-EARLY (NCT06909214)
- Testing
- Efgartigimod PH20 SC
- Where
- 18 sites in United States
- Volunteers
- 30 people
- Sponsor
- argenx
Healthy Volunteers
A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it.
- Trial name
- NCT07377396
- Testing
- ARGX-124
- Where
- Canada
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- argenx
Bullous Pemphigoid
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study.
- Trial name
- BALLAD+ (NCT05681481)
- Testing
- efgartigimod PH20 SC, Prednisone
- Where
- 40 sites in United States, Australia and 15 more
- Volunteers
- 64 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