RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症1
13多発性硬化症/視神経脊髄炎1

11. 重症筋無力症


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
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-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

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001829-26-IT
(EUCTR)
19/06/202022/01/2021A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD).A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder. - NA Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML)
Product Name: Soliris
Product Code: [Soliris]
INN or Proposed INN: ECULIZUMAB
Trade Name: MENVEO
Product Name: MENVEO
Product Code: [NA]
Other descriptive name: N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
Trade Name: Bexsero
Product Name: Bexsero
Product Code: [NA]
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
Trade Name: Hiberix
Product Name: Hiberix
Product Code: [NA]
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Trade Name: Prevenar 13
Product Name: Prevenar 13
Product Code: [NA]
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED)
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2;Phase 3United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of