Otezla ( DrugBank: - )
3 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 | 5 |
| 107 | 若年性特発性関節炎 | 6 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 1 |
56. ベーチェット病
臨床試験数 : 76 / 薬物数 : 110 - (DrugBank : 32) / 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 | 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 | ||
| 2 | EUCTR2019-002787-27-GR (EUCTR) | 20/05/2021 | 07/05/2021 | 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) | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Israel;Netherlands;Switzerland | ||
| 3 | EUCTR2014-002108-25-DE (EUCTR) | 17/06/2015 | 25/11/2014 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | 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 Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 4 | EUCTR2019-002787-27-FR (EUCTR) | 18/12/2020 | 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) | 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. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Israel;Netherlands;Switzerland | |||
| 5 | EUCTR2019-002787-27-NL (EUCTR) | 11/02/2021 | 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) | 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. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Spain;Israel;Netherlands;United Kingdom;Switzerland;Italy |
107. 若年性特発性関節炎
臨床試験数 : 441 / 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
| 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 | EUCTR2019-002788-88-NL (EUCTR) | 23/09/2021 | 18/02/2021 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 2 | EUCTR2019-002788-88-FR (EUCTR) | 15/04/2021 | 18/12/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands | ||
| 3 | EUCTR2019-002788-88-IT (EUCTR) | 11/03/2021 | 20/05/2021 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Spain;Belgium;Austria;Netherlands;Germany;Italy | ||
| 4 | EUCTR2019-002788-88-PL (EUCTR) | 28/01/2022 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A 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. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Poland;Austria;Netherlands;Italy | |||
| 5 | EUCTR2019-002788-88-BE (EUCTR) | 15/12/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A 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. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | Belgium;Austria;Netherlands | |||
| 6 | EUCTR2019-002788-88-AT (EUCTR) | 05/11/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A 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. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands;Italy |
162. 類天疱瘡（後天性表皮水疱症を含む。）
臨床試験数 : 83 / 薬物数 : 128 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142
| 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 | EUCTR2018-002564-10-NL (EUCTR) | 23/04/2019 | 23/04/2019 | PDE4 inhibitor (apremilast) in pemphigoid. | Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study. - SAMP trial | Pemphigoid;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 | Universitair Medisch Centrum Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands |