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


臨床試験数 : 315 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003272-41-DE
(EUCTR)
04/03/202204/01/2022A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis 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] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Korea, Republic of
2EUCTR2020-003272-41-ES
(EUCTR)
03/02/202228/09/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis 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] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Korea, Republic of
3EUCTR2020-003272-41-IT
(EUCTR)
13/12/202119/10/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis - Study of Pozelimab and Cemdisiran combination therapy in patients with Myasthenia Gravis 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] - Nervous System Diseases [C10]
Product Name: Cemdisiran
Product Code: [ALN-CC5]
INN or Proposed INN: Cemdisiran
Product Name: Pozelimab
Product Code: [REGN3918]
INN or Proposed INN: Pozelimab
Trade Name: Bexsero
Product Name: Bexsero
Product Code: [NA]
INN or Proposed INN: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254measured as amount of total protein containing the PorA P1.4
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E.COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
INN or Proposed INN: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
INN or Proposed INN: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN
Other descriptive name: RECOMBINANT NEISSERIA
REGENERON PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Korea, Republic of
4EUCTR2020-003272-41-PL
(EUCTR)
01/12/202121/10/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis 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] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Korea, Republic of
5NCT05070858
(ClinicalTrials.gov)
September 30, 202127/9/2021A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Symptomatic Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Pozelimab (REGN3918) + Cemdisiran;Drug: Cemdisiran;Other: PlaceboRegeneron PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll210Phase 3NULL