AMG 407 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
56ベーチェット病2
107若年性特発性関節炎1

56. ベーチェット病


臨床試験数 : 81 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-003024-41-ES
(EUCTR)
25/01/202325/11/2022Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866
MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG 407
INN or Proposed INN: Apremilast
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland
2EUCTR2019-002787-27-IT
(EUCTR)
24/05/202107/06/2021Apremilast study in children with active oral ulcers associated with Behçet's DiseaseA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled,Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN) - BEAN Subjects with active Behçet's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast
Product Code: [AMG 407]
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Israel;Netherlands;Switzerland;Italy

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-003024-41-ES
(EUCTR)
25/01/202325/11/2022Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866
MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG 407
INN or Proposed INN: Apremilast
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland