University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
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 2 Trials 
34 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Vu, Tuan
COURAGE-ALS, NCT04944784 / 2020-004040-29: A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

Terminated
3
489
Europe, Canada, US, RoW
Reldesemtiv, Placebo
Cytokinetics
Amyotrophic Lateral Sclerosis
07/23
07/23
COURAGE OLE, NCT05442775 / 2021-004727-33: A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

Terminated
3
71
Europe, Canada, US, RoW
Reldesemtiv
Cytokinetics, Cytokinetics Inc
Amyotrophic Lateral Sclerosis
06/23
06/23
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
NIMBLE, NCT05070858 / 2020-003272-41: A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis

Recruiting
3
235
Europe, Canada, Japan, US, RoW
Pozelimab + Cemdisiran, Cemdisiran, ALN-CC5, Placebo, Pozelimab, REGN3918
Regeneron Pharmaceuticals
Generalized Myasthenia Gravis
05/25
03/28
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
REAL, NCT05218668: Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis

Active, not recruiting
2
40
US, RoW
Fasudil (WP-0512)
Woolsey Pharmaceuticals
Amyotrophic Lateral Sclerosis
07/26
01/28
NCT04886518: Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1

Hourglass Jul 2022 - Dec 2022 : Efficacy and safety data for treatment of EDS in patients with Myotonic Dystrophy Type 1
Active, not recruiting
2
30
Canada, US
Pitolisant Oral Tablet, Placebo oral tablet
Harmony Biosciences, LLC
Myotonic Dystrophy 1, Excessive Daytime Sleepiness
10/23
10/24
NCT04146051: Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)

Recruiting
2
30
Canada, US
Descartes-08
Cartesian Therapeutics
Myasthenia Gravis, Generalized
03/25
03/26
ESPS, NCT06528392: Efgartigimod for Stiff Person Syndrome

Not yet recruiting
2
10
US
Efgartigimod
University of South Florida
Stiff-Person Syndrome
06/26
06/27
NCT06106672: Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis

Recruiting
1/2
54
US
CNP-106, Placebo
COUR Pharmaceutical Development Company, Inc.
Myasthenia Gravis, Generalized Myasthenia, AChR Myasthenia Gravis, MuSK MG
06/26
08/26
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
John, Suzana A
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

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