Clinical trials: Efgartigimod
Bioequivalence
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe…
- Trial name
- NCT05817435
- Testing
- efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- argenx
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
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
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
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
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
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
- 32 sites in United States, Georgia
- Volunteers
- 230 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
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
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
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
Generalized Myasthenia Gravis, gMG
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis…
- Conditions
- Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Generalized, Myasthenia Gravis
- Trial name
- ADAPT SERON (NCT06298552)
- Testing
- Efgartigimod IV
- Where
- 91 sites in United States, Belgium and 20 more
- Volunteers
- 119 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
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
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
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
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
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
- 19 sites in United States, Israel and 1 more
- Volunteers
- 115 people
- Sponsor
- Janssen Research & Development, LLC
Active Idiopathic Inflammatory Myopathy, Myositis
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
- Conditions
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA (NCT05523167)
- Testing
- EFG PH20 SC, PBO
- Where
- 202 sites in United States, Argentina and 34 more
- Volunteers
- 265 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