E6011 ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ3
93原発性胆汁性胆管炎1
96クローン病6

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02960490
(ClinicalTrials.gov)
November 26, 20163/11/2016A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to BiologicsA Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to BiologicsRheumatoid ArthritisDrug: E6011;Drug: PlaceboEisai Co., Ltd.NULLCompleted18 Years75 YearsAll64Phase 2Japan
2NCT02960438
(ClinicalTrials.gov)
November 2, 20163/11/2016A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to MethotrexateA Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to MethotrexateRheumatoid ArthritisDrug: E6011;Drug: PlaceboEisai Co., Ltd.NULLCompleted18 Years75 YearsAll190Phase 2Japan
3NCT02196558
(ClinicalTrials.gov)
May 26, 201416/7/2014A Study of E6011 in Japanese Subjects With Rheumatoid ArthritisA Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid ArthritisArthritis, RheumatoidDrug: E6011Eisai Co., Ltd.NULLCompleted20 Years64 YearsAll53Phase 1/Phase 2Japan

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03092765
(ClinicalTrials.gov)
May 29, 201724/3/2017Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidA Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidPrimary Biliary CholangitisDrug: E6011;Drug: PlaceboEA Pharma Co., Ltd.NULLTerminated20 Years74 YearsAll29Phase 2Japan

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
1JPRN-jRCT1031190056
30/09/201917/07/2019E6011-CS1 studyResearch for medicinal predictive marker on Crohn's disease - E6011-CS1 study Crohn's disease
Crohn's disease;D003424
Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.
Mikami YoheiEA Pharma Co.,Ltd.Not Recruiting>= 16age oldNot applicableBoth32N/AJapan
2EUCTR2018-002109-70-CZ
(EUCTR)
12/08/201927/12/2018A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel diseaseEarly phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable Active 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: E6011
INN or Proposed INN: Undetermined
Other descriptive name: IGG2 ANTIBODIES
EA Pharma Co., Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Czechia;Hungary;Czech Republic;Poland;Russian Federation;Japan
3NCT03733314
(ClinicalTrials.gov)
April 25, 20195/11/2018A Study of E6011 in Participants With Active Crohn's DiseaseEarly Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: E6011;Drug: PlaceboEA Pharma Co., Ltd.NULLActive, not recruiting18 Years64 YearsAll40Phase 2Czechia;Hungary;Japan;Poland;Russian Federation
4EUCTR2018-002109-70-HU
(EUCTR)
15/04/201920/11/2018A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel diseaseEarly phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable Active 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: E6011
INN or Proposed INN: Undetermined
Other descriptive name: IGG2 ANTIBODIES
EA Pharma Co., Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary;Poland;Japan
5NCT02249078
(ClinicalTrials.gov)
December 201423/9/2014A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseA Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: E6011;Drug: PlaceboEisai Inc.NULLWithdrawn18 YearsN/ABoth0Phase 1NULL
6NCT02039063
(ClinicalTrials.gov)
March 14, 20149/1/2014A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's DiseaseA Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseDrug: E6011 10 mg/kg;Drug: E6011 15 mg/kg;Drug: E6011 2 mg/kg;Drug: E6011 5 mg/kgEA Pharma Co., Ltd.NULLCompleted20 Years64 YearsAll28Phase 1/Phase 2Japan