96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | JPRN-jRCT1031190056 | 30/09/2019 | 17/07/2019 | E6011-CS1 study | Research 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 Yohei | EA Pharma Co.,Ltd.(Utilize AMED's funds) | Not Recruiting | >= 16age old | Not applicable | Both | 32 | N/A | Japan |
| 2 | EUCTR2018-002109-70-CZ (EUCTR) | 12/08/2019 | 27/12/2018 | A 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 disease | Early 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Czechia;Hungary;Czech Republic;Poland;Russian Federation;Japan | ||
| 3 | NCT03733314 (ClinicalTrials.gov) | April 25, 2019 | 5/11/2018 | A Study of E6011 in Participants With Active Crohn's Disease | Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: E6011;Drug: Placebo | EA Pharma Co., Ltd. | NULL | Recruiting | 18 Years | 64 Years | All | 40 | Phase 2 | Czechia;Hungary;Japan;Poland;Russian Federation |
| 4 | EUCTR2018-002109-70-HU (EUCTR) | 15/04/2019 | 20/11/2018 | A 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 disease | Early 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. | NULL | Authorised-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): no | Czech Republic;Hungary;Poland;Japan | ||
| 5 | NCT02249078 (ClinicalTrials.gov) | December 2014 | 23/9/2014 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease | A 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 Disease | Crohn's Disease | Drug: E6011;Drug: Placebo | Eisai Inc. | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1 | NULL |
| 6 | NCT02039063 (ClinicalTrials.gov) | March 14, 2014 | 9/1/2014 | A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease | A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease | Crohn's Disease | Drug: E6011 10 mg/kg;Drug: E6011 15 mg/kg;Drug: E6011 2 mg/kg;Drug: E6011 5 mg/kg | EA Pharma Co., Ltd. | NULL | Completed | 20 Years | 64 Years | All | 28 | Phase 1/Phase 2 | Japan |