EB8018 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 6 |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2019-000886-19-AT (EUCTR) | 06/05/2020 | 06/09/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | France;United States;Austria;Netherlands;Germany;United Kingdom | ||
| 2 | EUCTR2019-000886-19-NL (EUCTR) | 06/03/2020 | 17/09/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;France;Austria;Germany;Netherlands;United Kingdom | ||
| 3 | EUCTR2019-000886-19-FR (EUCTR) | 20/01/2020 | 26/07/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: None at this time Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: None at this time Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Germany;United Kingdom | ||
| 4 | EUCTR2019-000886-19-DE (EUCTR) | 26/11/2019 | 29/07/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Takeda Development Center Americas,Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | France;United States;Austria;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2019-000886-19-GB (EUCTR) | 06/11/2019 | 29/07/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence - TAK-018 for Prevention of the Recurrence of Postoperative Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;France;Austria;Netherlands;Germany;United Kingdom | ||
| 6 | NCT03709628 (ClinicalTrials.gov) | March 7, 2018 | 11/4/2018 | A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients | An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients | Crohn Disease | Drug: EB8018 (First-in-class FimH blocker) | Enterome | NULL | Completed | 18 Years | N/A | All | 8 | Phase 1 | Austria;France;Germany;Italy |