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

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002537-41-ES
(EUCTR)
08/03/202209/03/2022Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United 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
2EUCTR2021-002537-41-BG
(EUCTR)
02/02/202219/01/2022Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United 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
3NCT04987307
(ClinicalTrials.gov)
January 31, 202226/7/2021Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: Efavaleukin alfa;Drug: PlaceboAmgenNULLRecruiting18 Years80 YearsAll320Phase 2United States;Austria;Bulgaria;Japan;Korea, Republic of;Poland
4EUCTR2021-002537-41-DE
(EUCTR)
15/12/202113/10/2021Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United 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
5EUCTR2021-002537-41-NL
(EUCTR)
08/12/202113/10/2021Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United 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
6EUCTR2021-002537-41-HU
(EUCTR)
06/12/202125/10/2021Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United 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
7EUCTR2021-002537-41-IT
(EUCTR)
21/10/202126/01/2022Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United 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