97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2021-002537-41-ES (EUCTR) | 08/03/2022 | 09/03/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 2 | EUCTR2021-002537-41-BG (EUCTR) | 02/02/2022 | 19/01/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Spain;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 3 | NCT04987307 (ClinicalTrials.gov) | January 31, 2022 | 26/7/2021 | Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Efavaleukin alfa;Drug: Placebo | Amgen | NULL | Recruiting | 18 Years | 80 Years | All | 320 | Phase 2 | United States;Austria;Bulgaria;Japan;Korea, Republic of;Poland |
| 4 | EUCTR2021-002537-41-DE (EUCTR) | 15/12/2021 | 13/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 5 | EUCTR2021-002537-41-NL (EUCTR) | 08/12/2021 | 13/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 6 | EUCTR2021-002537-41-HU (EUCTR) | 06/12/2021 | 25/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Korea, Democratic People's Republic of;Ukraine;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 7 | EUCTR2021-002537-41-IT (EUCTR) | 21/10/2021 | 26/01/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. - - | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: [AMG 592] INN or Proposed INN: EFAVALEUKIN ALFA | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden |