Clinical trials: Efgartigimod
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
Generalized Myasthenia Gravis, gMG
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.
- Trial name
- ADAPT Jr + (NCT05374590)
- Testing
- Efgartigimod IV or Efgartigimod PH20 SC
- Where
- 16 sites in United States, Belgium and 8 more
- Volunteers
- 12 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
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
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
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
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
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
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
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
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
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
- 15 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
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