Clinical trials: Efgartigimod
Primary Immune Thrombocytopenia
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- ADVANCE SC+ (NCT04812925)
- Testing
- efgartigimod PH20 SC
- Where
- 83 sites in United States, Argentina and 23 more
- Volunteers
- 173 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
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
- Trial name
- NCT07284420
- Testing
- Efgartigimod IV, Empasiprubart IV
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 70 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
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
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.
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
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
Healthy Volunteers
A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers
This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.
- Trial name
- NCT04564066
- Testing
- efgartigimod IV, efgartigimod PH20 SC
- Where
- Netherlands
- Volunteers
- 54 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
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Generalized Myasthenia Gravis
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years.
- Trial name
- ADAPT Jr SC (NCT06392386)
- Testing
- Efgartigimod PH20 SC
- Where
- 22 sites in United States, Australia and 12 more
- Volunteers
- 12 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
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
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
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