Efgartigimod IV ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
11Myasthenia gravis9

11. Myasthenia gravis


Clinical trials : 315 Drugs : 232 - (DrugBank : 77) / Drug target genes : 46 - Drug target pathways : 126
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04980495
(ClinicalTrials.gov)
December 16, 202119/7/2021An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia GravisA Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: Efgartigimod concentrate for solution for infusion 20 mg/mLargenxNULLRecruiting18 YearsN/AAll72Phase 3United States;Georgia;Poland;Spain
2EUCTR2021-002504-12-ES
(EUCTR)
26/11/202102/12/2021An open-label study to investigate the clinical efficacy of different dosing regimens of efgartigimod IV in patients with generalized myasthenia gravisA Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG) - ADAPT NXT Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ARGX-113
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 3France;United States;Canada;Poland;Belgium;Spain;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy
3NCT04833894
(ClinicalTrials.gov)
October 26, 202116/3/2021Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia GravisOpen-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: Efgartigimod IVargenxNULLRecruiting2 Years18 YearsAll12Phase 2/Phase 3Belgium;France;Georgia;Poland;Spain
4EUCTR2020-004085-19-DE
(EUCTR)
31/05/202129/01/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
5EUCTR2020-004085-19-IT
(EUCTR)
26/04/202107/06/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
Product Code: [NA]
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
Product Code: [NA]
INN or Proposed INN: EFGARTIGIMOD ALFA
ARGENX BVNULLNot RecruitingFemale: yes
Male: yes
76Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
6EUCTR2020-004085-19-NL
(EUCTR)
19/03/202105/01/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNot RecruitingFemale: yes
Male: yes
76Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina
7EUCTR2020-004085-19-BE
(EUCTR)
16/03/202112/01/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3Georgia;Germany;Netherlands;Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Japan;Bosnia and Herzegovina
8EUCTR2020-004085-19-HU
(EUCTR)
24/02/202129/12/2020Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod PH20 SC
INN or Proposed INN: EFGARTIGIMOD ALFA
Product Name: Efgartigimod IV
INN or Proposed INN: EFGARTIGIMOD ALFA
argenx BVNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina
9NCT04735432
(ClinicalTrials.gov)
February 5, 202126/1/2021Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: efgartigimod PH20 SC;Biological: efgartigimod IVargenxNULLCompleted18 YearsN/AAll111Phase 3United States;Belgium;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain