11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

  
7 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2018-003243-39-PT
(EUCTR)
15/06/202006/02/2020Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of
2EUCTR2018-003243-39-GB
(EUCTR)
11/02/202008/10/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
3EUCTR2018-003243-39-CZ
(EUCTR)
02/01/202013/09/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
4EUCTR2018-003243-39-DK
(EUCTR)
20/09/201922/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of
5EUCTR2018-003243-39-DE
(EUCTR)
30/07/201925/03/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Trade Name: Ultomiris 1,100 mg/11 mL
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Portugal
6EUCTR2018-003243-39-NL
(EUCTR)
22/07/201901/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Denmark;Netherlands;Germany;Japan;Korea, Republic of
7EUCTR2018-003243-39-IT
(EUCTR)
17/06/201922/01/2021Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - NA Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of