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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2022-003024-41-ES (EUCTR) | 25/01/2023 | 25/11/2022 | Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland | ||
| 2 | EUCTR2019-002787-27-IT (EUCTR) | 24/05/2021 | 07/06/2021 | Apremilast study in children with active oral ulcers associated with Behçet's Disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2022-003024-41-ES (EUCTR) | 25/01/2023 | 25/11/2022 | Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland |