Apremilast 10 mg ( DrugBank: Apremilast )


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3
107若年性特発性関節炎7

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
1EUCTR2019-002787-27-GR
(EUCTR)
20/05/202107/05/2021Apremilast 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) 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
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Israel;Netherlands;Switzerland
2EUCTR2019-002787-27-NL
(EUCTR)
11/02/2021Apremilast 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) 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
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3France;Greece;Spain;Israel;Netherlands;United Kingdom;Switzerland;Italy
3EUCTR2019-002787-27-FR
(EUCTR)
18/12/2020Apremilast 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) 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
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3France;Israel;Netherlands;Switzerland

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
1EUCTR2019-002788-88-GR
(EUCTR)
14/04/202201/02/2022Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Poland;Belgium;Austria;Netherlands;Italy
2EUCTR2019-002788-88-NL
(EUCTR)
23/09/202118/02/2021Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Belgium;Austria;Netherlands;Italy
3EUCTR2019-002788-88-FR
(EUCTR)
15/04/202118/12/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Belgium;Austria;Netherlands
4EUCTR2019-002788-88-IT
(EUCTR)
11/03/202120/05/2021Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) - PEAPOD Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;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 20 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE
Product Name: Apremilast 30 mg
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 10 mg
Product Code: [AMG407]
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;Spain;Belgium;Austria;Netherlands;Germany;Italy
5EUCTR2019-002788-88-AT
(EUCTR)
11/01/202105/11/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Poland;Belgium;Austria;Netherlands;Italy
6EUCTR2019-002788-88-PL
(EUCTR)
28/01/2022Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3France;Belgium;Poland;Austria;Netherlands;Italy
7EUCTR2019-002788-88-BE
(EUCTR)
15/12/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
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: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3Belgium;Austria;Netherlands