Clinical trials: Efgartigimod, open to volunteers
Myasthenia Gravis
Efgartigimod for Consolidation Therapy in gMG
The goal of this observational study is to evaluate the efficacy and safety of consolidation therapy with corticosteroids and/or immunosuppressants combined with efgartigimod in patients with generalized myasthenia gravis after…
- Trial name
- NCT07079020
- Volunteers
- 130 people
- Sponsor
- Da, Yuwei, M.D.
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
- 35 sites in United States, Georgia and 1 more
- Volunteers
- 230 people
- Sponsor
- argenx
Myasthenia Gravis
A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
- Trial name
- NCT07673744
- Testing
- Ublituximab
- Where
- 7 sites in United States
- Volunteers
- 120 people
- Sponsor
- TG Therapeutics, Inc.
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
- 17 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, Generalized
Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod
Generalized Myasthenia Gravis (gMG) is a rare chronic autoimmune disorder causing muscle weakness and fatigue, primarily due to autoantibodies that disrupt neuromuscular junction function.
- Trial name
- OPTIMAGE (NCT07072988)
- Testing
- Efgartigimod
- Where
- 9 sites in France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Stiff Person Syndrome
VYVGART (Hytrulo) in Patients With Stiff Person Syndrome (SPS)
Stiff Person Syndrome (SPS) is a rare autoimmune disorder, characterized by: a) incapacitating diffuse muscle stiffness prominent in the axial, abdominal and thoracolumbar paraspinal muscles leading to hyperlordosis, difficulty…
- Trial name
- NCT07860021
- Testing
- VYVGART Hytrulo
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Thomas Jefferson University
Efgartigimod, Intravenous Immunoglobulin
EFG vs IVIG in TAMG
This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor…
- Conditions
- Efgartigimod, Intravenous Immunoglobulin, Myasthenia Gravis Associated With Thymoma
- Trial name
- NCT07231523
- Testing
- Efgartigimod + Thymectomy, Intravenous immunglobulin + Thymectomy
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shanghai Zhongshan Hospital
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 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
Guillain-Barre Syndrome (GBS)
Efgartigimod for the Treatment of Guillain-Barré Syndrome
The goal of this clinical trial is to evaluating the efficacy and safety of efgartigimod in the treatment of Guillain-Barré Syndrome and exploring the immunological mechanisms of efgartigimod therapy in Guillain-Barré Syndrome.
- Trial name
- NCT06885762
- Testing
- efgartigimod
- Volunteers
- 20 people
- Sponsor
- Zhongming Qiu
Myasthenia Gravis
Perioperative Efgartigimod for Thymoma and Myasthenia Gravis
It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated.
- Trial name
- NCT06221501
- Testing
- Efgartigimod Alfa
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhongshan Hospital
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
NMOSD
Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder
This study aims to evaluate the efficacy and safety of different monoclonal antibody in the acute phase of neuromyelitis optica spectrum disorder (MAAP-NMO).
- Trial name
- NCT07182409
- Volunteers
- 40 people
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
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
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
- 51 sites in Belgium, Bulgaria and 12 more
- Volunteers
- 230 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
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
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
Myasthenia Gravis
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the…
- Trial name
- EPIC (NCT07217587)
- Testing
- Nipocalimab, Efgartigimod
- Where
- 31 sites in United States, Germany and 3 more
- Volunteers
- 115 people
- Sponsor
- Janssen Research & Development, LLC