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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000886-19-AT
(EUCTR)
06/05/202006/09/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2France;United States;Austria;Netherlands;Germany;United Kingdom
2EUCTR2019-000886-19-NL
(EUCTR)
06/03/202017/09/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Germany;Netherlands;United Kingdom
3EUCTR2019-000886-19-FR
(EUCTR)
20/01/202026/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA 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 subsidiaryNULLAuthorised-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): noUnited States;France;Germany;United Kingdom
4EUCTR2019-000886-19-DE
(EUCTR)
26/11/201929/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2France;United States;Austria;Netherlands;Germany;United Kingdom
5EUCTR2019-000886-19-GB
(EUCTR)
06/11/201929/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA 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 subsidiaryNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Netherlands;Germany;United Kingdom
6NCT03709628
(ClinicalTrials.gov)
March 7, 201811/4/2018A Study of a FimH Blocker, EB8018, in Crohn's Disease PatientsAn Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease PatientsCrohn DiseaseDrug: EB8018 (First-in-class FimH blocker)EnteromeNULLCompleted18 YearsN/AAll8Phase 1Austria;France;Germany;Italy