Clinical trials: Efgartigimod
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
- 42 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 230 people
- Sponsor
- argenx
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
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
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
Autoimmune Encephalitis (AE)
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE).
- Trial name
- Polaris (NCT07583641)
- Testing
- Efgartigimod PH20 (ARGX-113) SC
- Where
- 2 sites in United States
- Volunteers
- 170 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
Healthy Volunteers
Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV
This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.
- Trial name
- NCT05163834
- Testing
- Efgartigimod, PNEUMOVAX 23
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- argenx
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CIDP
Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options.
- Trial name
- NCT04777734
- Testing
- Efgartigimod PH20 SC
- 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
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
Antibody-mediated Rejection
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.
- Trial name
- Shamrock (NCT06503731)
- Testing
- Efgartigimod PH20 SC - prefilled syringe
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 33 people
- Sponsor
- argenx
Systemic Sclerosis (SSc)
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis.
- Trial name
- eSScape (NCT06655155)
- Testing
- Efgartigimod PH20 SC
- Where
- 79 sites in United States, Argentina and 22 more
- Volunteers
- 87 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 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
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
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