ARGX-117 IV ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー3

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー


臨床試験数 : 167 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2021-003302-50-ES
(EUCTR)
08/03/202202/11/2021A 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 neuropathyA Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA Multifocal Motor Neuropathy
MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ARGX-117 IV
Product Code: ARGX-117 IV
INN or Proposed INN: not defined
Other descriptive name: ARGX-117
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2France;United States;Canada;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy
2EUCTR2021-003302-50-IT
(EUCTR)
17/02/202226/11/2021A 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 neuropathyA Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy,Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA Multifocal Motor Neuropathy
MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ARGX-117 IV
Product Code: [ARGX-117 IV]
Trade Name: Act-HiB
Product Name: Haemophilus type b vaccine (conjugated)
Product Code: [.]
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Trade Name: Intratect
Product Name: Human normal immunoglobulin (IVIg)
Product Code: [-]
INN or Proposed INN: Human normal immunoglobulin (IVIg)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Menjugate
Product Name: Group C meningococcal conjugate vaccine
Product Code: [J07AH07]
INN or Proposed INN: Group C meningococcal conjugate vaccine
Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE
Trade Name: Prevenar 13 sospensione per iniezione
Product Name: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Product Code: [NA]
INN or Proposed INN: VACCINO PNEUMOCOCCICO SACCARIDICO
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy
3EUCTR2021-003302-50-NL
(EUCTR)
14/02/202227/12/2021A study for adult patients with Multifocal Motor Neuropathy comparing 2 doses of ARGX-117A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA Multifocal Motor Neuropathy
MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ARGX-117 IV
Product Code: ARGX-117 IV
INN or Proposed INN: not defined
Other descriptive name: ARGX-117
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy