Clinical trials: Efgartigimod
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.
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
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
Myasthenia Gravis, Autoimmune Diseases
Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis
Title: The Efficacy, Safety, and PK/PD of Efgartigimod Followed by Telitacicept in Generalized Myasthenia Gravis: Protocol of a Randomized Controlled Trial Objective: This study aims to evaluate the efficacy, safety, and…
- Conditions
- Myasthenia Gravis, Autoimmune Diseases, Neuromuscular Diseases
- Trial name
- NCT06827587
- Testing
- Efgartigimod + Telitacicept (1-week interval) group, Efgartigimod + Telitacicept (2-week interval) group, Telitacicept-only group
- Volunteers
- 60 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
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
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
Primary Immune Thrombocytopenia (ITP)
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 patients with primary ITP.
- Trial name
- ADVANCE2 (NCT04274452)
- Testing
- efgartigimod
- 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
Optic Neuritis
Efgartigimod for the Treatment of Acute Optic Neuritis
The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis (optic nerve inflammation).
- Trial name
- PET-AON (NCT06453694)
- Testing
- Efgartigimod Alfa
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Anastasia Vishnevetsky, MD, MPH
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
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
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
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
Renal Impairment
A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod
A study to test how kidney problems influence the blood concentrations of efgartigimod
- Trial name
- NCT05927415
- Testing
- Efgartigimod IV
- Where
- 2 sites in Germany
- Volunteers
- 33 people, healthy volunteers welcome
- 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
Immune-mediated Thrombotic Thrombocytopenic Purpura
A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Immune-mediated Thrombotic thrombocytopenic purpura (iTTP) is a rare, autoimmune disorder characterized by life-threatening episodes of thrombocytopenia, microangiopathic hemolytic anemia and organ damage.
- Trial name
- NCT06831058
- Testing
- efgartigimod
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Minnesota
Healthy Volunteers
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of…
- Trial name
- NCT04073589
- Testing
- ARGX-113 with rHuPH20
- Where
- Netherlands
- Volunteers
- 33 people, healthy volunteers welcome
- 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
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
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