Clinical trials: sponsored by 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
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
Primary Sjögren's Syndrome
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
- Trial name
- rho (NCT05817669)
- Testing
- Efgartigimod
- Where
- 17 sites in Belgium, Hungary and 2 more
- Volunteers
- 34 people
- Sponsor
- argenx
Immune Thrombocytopenia
ITP Registry and Accompanying Biospecimen Collection
The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.
- Trial name
- ITP-Registry (NCT05152238)
- Where
- 64 sites in Germany
- Volunteers
- 1,100 people
- Sponsor
- Jena University Hospital
Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG).
- Conditions
- Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations, AChR Myasthenia Gravis
- Trial name
- NCT06860633
- Testing
- Efgartigimod
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Postural Orthostatic Tachycardia Syndrome
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic…
- Trial name
- POTS (NCT05633407)
- Testing
- Efgartigimod
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
This was a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who…
- Trial name
- ADDRESS+ (NCT04598477)
- Testing
- efgartigimod PH20 SC, prednisone
- Where
- 127 sites in United States, Australia and 19 more
- Volunteers
- 183 people
- Sponsor
- argenx
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
Membranous Nephropathy
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).
- Trial name
- NCT05810961
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 8 people
- Sponsor
- argenx
Myasthenia Gravis Crisis
Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis
Efgartigimod in Myasthenic Crisis Background Myasthenia gravis (MG) is a prevalent autoimmune disorder affecting neuromuscular junctions, characterized by weakness in skeletal muscles.
- Trial name
- NCT06688253
- Testing
- IV efgartigimod
- Where
- Israel
- Volunteers
- 16 people
- Sponsor
- Rambam Health Care Campus
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
- Trial name
- ADVANCE SC (NCT04687072)
- Testing
- Efgartigimod PH20 SC
- Where
- 200 sites in United States, Argentina and 30 more
- Volunteers
- 207 people
- Sponsor
- argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult…
- Trial name
- ADDRESS (NCT04598451)
- Testing
- efgartigimod PH20 SC, prednisone
- Where
- 134 sites in United States, Australia and 19 more
- Volunteers
- 222 people
- Sponsor
- argenx
Myasthenia Gravis
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle…
- Trial name
- NCT02965573
- Testing
- ARGX-113
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 24 people
- Sponsor
- argenx
Healthy Volunteers
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy…
- Trial name
- NCT05670704
- Testing
- ARGX-119
- Where
- Netherlands
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Study to Assess the 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 a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
- Trial name
- ADHERE (NCT04281472)
- Testing
- efgartigimod PH20 SC in stage B
- Where
- 216 sites in United States, Austria and 23 more
- Volunteers
- 322 people
- Sponsor
- argenx