Clinical trials: sponsored by 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
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
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
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
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
- 12 people
- Sponsor
- argenx
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
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be…
- Trial name
- NCT06298565
- Testing
- efgartigimod
- Where
- 35 sites in United States, Austria and 4 more
- Volunteers
- 680 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
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
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
Bullous Pemphigoid
A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity…
- Trial name
- BALLAD (NCT05267600)
- Testing
- efgartigimod PH20 SC, Prednisone
- Where
- 129 sites in United States, Australia and 19 more
- Volunteers
- 98 people
- Sponsor
- argenx
Dermatomyositis, Myositis
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants.
- Trial name
- empacific (NCT06284954)
- Testing
- Empasiprubart IV
- Where
- 28 sites in United States, Georgia and 5 more
- Volunteers
- 3 people
- Sponsor
- argenx
Healthy Volunteer
A Study to Assess the Safety of ARGX-109 in Healthy Volunteers
This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body.
- Trial name
- NCT06799416
- Testing
- ARGX-109
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- argenx