University of North Carolina - Chapel Hill
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 67 Trials 
68 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Key, Nigel
AHAEmi, NCT05345197: Emicizumab in Patients With Acquired Hemophilia A

Recruiting
2
51
US
emicizumab, Hemlibra (R)
University of Washington, Genentech, Inc.
Acquired Hemophilia A
07/25
12/25
NCT04055051: ATHN 11: Liver Transplantation Outcomes Study

Completed
N/A
86
US
American Thrombosis and Hemostasis Network, BioMarin Pharmaceutical
Hemophilia A and B, Liver Transplantation
12/22
12/22
ATHN Transcends, NCT04398628: A Natural History Study of Non-Neoplastic Hematologic Disorders

Recruiting
N/A
3000
US
American Thrombosis and Hemostasis Network, Pfizer, Hemophilia of Georgia, Inc., Genentech, Inc., Hemab Therapeutics, CSL Behring, Sanofi, Novo Nordisk A/S
Hematologic Disorder, Bleeding Disorder, Connective Tissue Disorder, Hemophilia, Thrombosis, Von Willebrand Diseases, Thrombophilia, Rare Bleeding Disorder, Platelet Disorder, Factor IX Deficiency, Factor VIII Deficiency, Thalassemia, Sickle Cell Disease
06/35
12/35
Dellon, Evan S
DESTRICT, NCT06352073: Dupilumab for Eosinophilic Esophagitis With Severe Strictures

Recruiting
4
30
US
Dupilumab, Dupilumab Pre-filled Syringe, Dupixent
University of North Carolina, Chapel Hill, Regeneron Pharmaceuticals, Sanofi
Eosinophilic Esophagitis, EoE
11/25
04/26
FLUTE-3, NCT05634746: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3)

Completed
3
218
Canada, US
APT-1011, Placebo oral tablet, Esophagogastroduodenoscopy
Ellodi Pharmaceuticals, LP
Eosinophilic Esophagitis
08/24
08/24
DEGS, NCT03678545: Dupilumab in Eosinophilic Gastritis

Active, not recruiting
2
41
US
Dupilumab (blinded), Placebo (blinded), Dupilumab (open-label)
Children's Hospital Medical Center, Cincinnati, Regeneron Pharmaceuticals, National Institutes of Health (NIH)
Eosinophilic Gastritis, Eosinophilic Gastroenteritis
03/24
11/24
Woods, Michael
NCT05156047: A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Completed
3
214
US
Open-label pitolisant, Double-blind placebo, Double-blind pitolisant
Harmony Biosciences, LLC
Idiopathic Hypersomnia
09/23
09/23
ALTITUDE, NCT04171492: Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules

Recruiting
N/A
2000
Canada, US
Biodesix, Inc.
Nodule Solitary Pulmonary, Non-small Cell Carcinoma
12/24
12/26
Boggess, Kim
DECIDE CGM, NCT06490874: Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT

Not yet recruiting
N/A
300
US
CGM device - Metformin group, CGM device - Insulin group
Ohio State University, The George Washington University Biostatistics Center, DexCom, Inc.
Gestational Diabetes Mellitus, Pregnancy, High Risk
12/29
12/30
Ma, Alice D
KEYSTONE 1, NCT06297486: Study of a Gene Therapy Treatment for Hemophilia A

Withdrawn
3
85
US
SPK-8011, AAV-Spark200-BDD-hFVIII, Dirloctocogene samoparvovec
Spark Therapeutics, Inc.
Hemophilia A
05/27
09/35
AHAEmi, NCT05345197: Emicizumab in Patients With Acquired Hemophilia A

Recruiting
2
51
US
emicizumab, Hemlibra (R)
University of Washington, Genentech, Inc.
Acquired Hemophilia A
07/25
12/25
AusNanoMED, NCT06495671: Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

Not yet recruiting
N/A
30
RoW
Magnetically enhanced diffusion, PULSE Nanomed System
University of Melbourne, Monash University, Euphrates Vascular, Inc.
Ischemic Stroke, Stroke
12/26
03/27
Burbank, Allison
GSK AR ELF, NCT04670627: Biomarkers in Nasal Samples of Seasonal Allergic Rhinitics

Completed
N/A
92
US
University of North Carolina, Chapel Hill, GlaxoSmithKline
Seasonal Allergic Rhinitis, Rhinovirus
04/23
04/23
Battarbee, Ashley N
DECIDE CGM, NCT06490874: Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT

Not yet recruiting
N/A
300
US
CGM device - Metformin group, CGM device - Insulin group
Ohio State University, The George Washington University Biostatistics Center, DexCom, Inc.
Gestational Diabetes Mellitus, Pregnancy, High Risk
12/29
12/30
Dittus, Christopher
NCT04548648: A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas

Recruiting
2
16
US
Acalabrutinib, ACP-196, CALQUENCE
UNC Lineberger Comprehensive Cancer Center, AstraZeneca
Central Nervous System Lymphoma
02/28
02/33
NCT05498220: Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Recruiting
2
44
US
Polatuzumab vedotin (PV), Rituximab, Hyaluronidase, Gemcitabine, Cisplatin, Dexamethasone, GCSF
UNC Lineberger Comprehensive Cancer Center, Genentech, Inc.
Diffuse Large B-cell Lymphoma
08/28
08/28
AMC-105, NCT04139304: A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma

Active, not recruiting
1
15
US
Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, Daratumumab, Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Doxorubicin Hydrochloride, 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex, Etoposide, Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Vincristine, LEUROCRISTINE, VCR, Vincrystine, Vincristine Sulfate, Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
AIDS Malignancy Consortium, National Cancer Institute (NCI), Janssen Scientific Affairs, LLC, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, AIDS and Cancer Specimen Resource, The Emmes Company, LLC
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
07/25
08/27
Khagi, Simon
METIS, NCT02831959: Pivotal, Open-label, Randomized Study of Radiosurgery with or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases from Non-small Cell Lung Cancer (NSCLC).

Completed
3
298
Europe, Canada, US, RoW
NovoTTF-200M device, Best Standard of Care
NovoCure GmbH
Brain Metastases from Non-small Cell Lung Cancer (NSCLC)
11/24
11/24
EF-41, NCT06556563: /KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Recruiting
3
741
Japan, US
Optune® device, TTFields, Temozolomide, Pembrolizumab, Placebo
NovoCure GmbH, Merck Sharp & Dohme LLC
Glioblastoma
04/29
04/29
NCT06061809: N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma

Recruiting
2
20
US
Bevacizumab, Avastin, PD-L1 t-haNK, N-803, ALT-803, Anktiva
ImmunityBio, Inc.
Glioblastoma
12/29
12/30
LIBERATE, NCT05383872: Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects with GlioBlastoma Brain Tumors

Recruiting
N/A
57
Canada, US
Focused Ultrasound (Exablate Model 4000)
InSightec
Glioblastoma, Glioma, Liquid Biopsy
12/24
03/25
Gortler, Zachary
NCT04927702: Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

Terminated
N/A
47
US
Synthetic Hybrid-Scale Fiber Matrix, Restrata, Standard of Care, Living Cellular Skin Substitute, Apligraf
Acera Surgical, Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
07/24
08/24
Mills, Katie
RAPID, NCT04287621: Registry of Asthma Patients Initiating DUPIXENT®

Active, not recruiting
N/A
718
Europe, Canada, Japan, US
DUPIXENT®, dupilumab, REGN668, SAR231893
Regeneron Pharmaceuticals, Sanofi
Asthma
07/26
07/26
Titter, Julie
NCT03152162 / 2014-005514-31: A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

Terminated
N/A
102
US
iTotal PS KRS, ConforMIS iTotal PS
Restor3D
Osteoarthritis, Knee
11/22
11/22
Vavalle, John
NCT03735667: ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Active, not recruiting
N/A
1948
Canada, US
ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System, ACURATE Prime™ Transfemoral TAVR System XL
Boston Scientific Corporation
Aortic Stenosis
06/24
09/34
NCT04482062: TRISCEND II Pivotal Trial

Active, not recruiting
N/A
1070
Europe, US
Edwards EVOQUE System, Transcatheter tricuspid valve replacement, Optimal Medical Therapy
Edwards Lifesciences
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
06/24
12/29
CLASP II TR, NCT04097145: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Recruiting
N/A
870
Canada, US
Edwards PASCAL System, Transcatheter tricuspid valve repair (TTVr), Optimal Medical Therapy
Edwards Lifesciences
Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
12/27
12/31
NCT03142152: The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Recruiting
N/A
300
Europe, US
Carillon Mitral Contour System, Carillon, Percutaneous mitral valve repair, Guideline Directed Heart Failure Medication
Cardiac Dimensions, Inc.
Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases, Heart Valve Diseases
12/26
12/30
Traub, Rebecca
iMMersioN, NCT05988073: A Prospective Longitudinal Study in Adults with Multifocal Motor Neuropathy

Recruiting
N/A
150
Europe, Canada, Japan, US, RoW
argenx
Multifocal Motor Neuropathy
11/25
11/25
Choo, Joseph
NCT03904147: TRILUMINATE Pivotal Trial

Active, not recruiting
N/A
572
Europe, Canada, US
TriClipTM Device
Abbott Medical Devices
Tricuspid Regurgitation
11/22
04/29
CLASP IID, NCT03706833: Edwards PASCAL /IIF Pivotal Clinical Trial

Recruiting
N/A
1247
Europe, Canada, US
Edwards PASCAL System, Transcatheter Mitral Valve repair (TMVr), Abbott Mitraclip System
Edwards Lifesciences
Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
01/25
04/30
NCT03735667: ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Active, not recruiting
N/A
1948
Canada, US
ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System, ACURATE Prime™ Transfemoral TAVR System XL
Boston Scientific Corporation
Aortic Stenosis
06/24
09/34
NCT04482062: TRISCEND II Pivotal Trial

Active, not recruiting
N/A
1070
Europe, US
Edwards EVOQUE System, Transcatheter tricuspid valve replacement, Optimal Medical Therapy
Edwards Lifesciences
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
06/24
12/29
ASPIRE PH, NCT04555161: Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System

Recruiting
N/A
30
US
Aria CV Pulmonary Hypertension System, Aria CV PH System
Aria CV, Inc
Pulmonary Arterial Hypertension, Pulmonary Hypertension, Right Heart Dysfunction
10/25
10/26
NCT03523416: Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Active, not recruiting
N/A
71
US
Transcatheter Atrial Shunt System
Edwards Lifesciences
Heart Failure
12/23
11/28
NCT03997305: AltaValve Early Feasibility Study Protocol

Recruiting
N/A
15
US
AltaValve
4C Medical Technologies, Inc.
Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
09/25
09/25
APOLLO, NCT03242642: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Recruiting
N/A
1056
Europe, Canada, US
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Cardiovascular
Mitral Valve Regurgitation
10/26
09/36
Sesaba, Kassaye
stAAAble, NCT06001918: Nectero EAST System Clinical Study

Recruiting
2/3
400
US
Nectero EAST System
Nectero Medical, Inc.
Abdominal Aortic Aneurysm
03/27
12/29
NCT05198674: SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

Recruiting
N/A
1400
Europe, US, RoW
Renal Denervation (Symplicity Spyral™), Renal Angiography, Renal Denervation
Medtronic Vascular
Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
11/26
11/29
REVIT, NCT06394739: RevCore for In Stent Thrombosis

Recruiting
N/A
100
US
Thrombectomy, RevCore Thrombectomy
Inari Medical
In-stent Thrombosis
12/25
12/26
NCT05409976: The GORE® VIAFORT Vascular Stent IVC Study

Active, not recruiting
N/A
111
Europe, US, RoW
GORE® VIAFORT Vascular Stent
W.L.Gore & Associates
Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis, Venous Ulcer, Venous Stenosis, Venous Occlusion, Vein Thrombosis, Vein Occlusion, Vein Disease
01/25
01/29
NCT05489588: The GORE® VIAFORT Vascular Stent Iliofemoral Study

Active, not recruiting
N/A
165
US
GORE® VIAFORT Vascular Stent
W.L.Gore & Associates
Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis, Venous Ulcer, Venous Stenosis, Venous Occlusion, Vein Thrombosis, Vein Occlusion, Vein Disease
04/25
04/29
ROADSTER 3, NCT05365490: Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients with Significant Carotid Artery Disease

Active, not recruiting
N/A
344
US
Transcarotid Artery Revascularization (TCAR), Carotid Revascularization, Carotid Artery Stenting
Silk Road Medical
Carotid Artery Diseases
09/25
09/25
JAGUAR, NCT05064540: Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Recruiting
N/A
450
US
Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
Endologix
AAA, AAA - Abdominal Aortic Aneurysm
12/28
12/28
Choudhury, Nayeem
diSArm, NCT05184764: Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia

Recruiting
1/2
50
US, RoW
AP-SA02, Placebo
Armata Pharmaceuticals, Inc., United States Department of Defense
Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus
12/24
03/25
Coppieters, Sabine
ADDRESS, NCT04598451 / 2020-002915-23: A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

Completed
3
222
Europe, Japan, US, RoW
efgartigimod PH20 SC, Placebo, prednisone
argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
08/23
08/23
ADAPT NXT, NCT04980495 / 2021-002504-12: An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

Active, not recruiting
3
69
Europe, Canada, US, RoW
Efgartigimod concentrate for solution for infusion 20 mg/mL, Efgartigimod IV
argenx
Generalized Myasthenia Gravis
08/23
05/26
ADVANCE SC, NCT04687072 / 2020-004032-21: A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Completed
3
207
Europe, Japan, US, RoW
Efgartigimod PH20 SC, ARGX-113 PH20 SC, Placebo PH20 SC
argenx, argenx BV
Primary Immune Thrombocytopenia
10/23
10/23
NCT06298552: A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Recruiting
3
110
Europe, Canada, US, RoW
Efgartigimod IV, Placebo IV
argenx
Generalized Myasthenia Gravis
07/25
07/27
ADDRESS+, NCT04598477 / 2020-002917-16: 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)

Terminated
3
183
Europe, Japan, US, RoW
efgartigimod PH20 SC, prednisone
argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
03/24
03/24
BALLAD+, NCT05681481 / 2021-003063-10: A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants with Bullous Pemphigoid

Active, not recruiting
3
160
Europe, Japan, US, RoW
efgartigimod PH20 SC, Prednisone
argenx, argenx BV
Bullous Pemphigoid
01/26
03/26
ADVANCE SC+, NCT04812925 / 2020-004033-20: A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients with Primary Immune Thrombocytopenia

Active, not recruiting
3
173
Europe, Japan, US, RoW
efgartigimod PH20 SC, ARGX-113 PH20 SC
argenx
Primary Immune Thrombocytopenia
10/26
10/26
ALKIVIA+, NCT05979441: A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults with Active Idiopathic Inflammatory Myopathy

Enrolling by invitation
3
240
Europe, US, RoW
EFG PH20 SC
argenx
Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome
09/27
09/27
NCT04833894 / 2020-005841-18: Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children with Generalized Myasthenia Gravis

Recruiting
2/3
12
Europe, Canada, US, RoW
Efgartigimod IV
argenx
Generalized Myasthenia Gravis
03/27
03/27
BALLAD, NCT05267600 / 2021-003087-27: A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants with Bullous Pemphigoid

Completed
2/3
98
Europe, Japan, US, RoW
efgartigimod PH20 SC, placebo, Prednisone
argenx, argenx BV
Bullous Pemphigoid
09/24
09/24
NCT05374590 / 2021-002460-46: Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children with Generalized Myasthenia Gravis

Enrolling by invitation
2/3
12
Europe, US
Efgartigimod IV or Efgartigimod PH20 SC
argenx
Generalized Myasthenia Gravis
09/28
09/28
ALKIVIA, NCT05523167 / 2021-001277-23: A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active Idiopathic Inflammatory Myopathy.

Recruiting
2/3
240
Europe, Canada, Japan, US, RoW
EFG PH20 SC, PBO
argenx, argenx BV
Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome
12/26
02/27
ADHERE, NCT04281472 / 2019-003076-39: 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)

Completed
2
322
Europe, Japan, US, RoW
efgartigimod PH20 SC in stage B, placebo in stage B
argenx
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
05/23
05/23
ARDA, NCT05225675 / 2021-003302-50: A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults with Multifocal Motor Neuropathy

Completed
2
54
Europe, Canada, US
ARGX-117, Placebo
argenx
Multifocal Motor Neuropathy
06/24
06/24
NCT05810961: A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)

Terminated
2
8
RoW
efgartigimod IV, placebo
argenx, Zai Lab Pty. Ltd.
Membranous Nephropathy
08/24
08/24
NCT05810948: A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Lupus Nephritis (ZL-1103-013)

Active, not recruiting
2
73
RoW
efgartigimod IV, Placebo
argenx, Zai Lab (Shanghai) Co., Ltd.
Lupus Nephritis
07/25
09/25
ARDA+, NCT05405361 / 2021-004998-32: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy

Active, not recruiting
2
51
Europe, Canada, US
ARGX-117, Placebo
argenx, argenx BV
Multifocal Motor Neuropathy (MMN)
09/26
09/26
ADHERE+, NCT04280718 / 2019-003107-35: A Study to Assess the Long-term 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)

Active, not recruiting
2
229
Europe, Japan, US, RoW
Efgartigimod PH20 SC, ARGX-113
argenx
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
03/27
03/27
NCT05817435: A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults

Completed
1
120
US
efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
argenx
Bioequivalence
05/23
05/23
ARGX-119-2201, NCT05670704: A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants

Completed
1
112
NA
ARGX-119, Placebo
argenx
Healthy Volunteers
08/24
08/24
NCT05927415: A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

Completed
1
33
Europe
Efgartigimod IV
argenx
Renal Impairment
06/24
06/24
NCT06299748: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

Recruiting
N/A
279
US
Efgartigimod, Vyvgart
argenx
Myasthenia Gravis
12/33
12/33
iMMersioN, NCT05988073: A Prospective Longitudinal Study in Adults with Multifocal Motor Neuropathy

Recruiting
N/A
150
Europe, Canada, Japan, US, RoW
argenx
Multifocal Motor Neuropathy
11/25
11/25
Ruggles, Phoebe R
No trials found

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