49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199

  
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003509-72-FR
(EUCTR)
21/10/202110/03/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
2EUCTR2020-003509-72-BG
(EUCTR)
31/08/202101/06/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
3EUCTR2020-003509-72-AT
(EUCTR)
12/08/202111/05/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of
4EUCTR2020-003509-72-IT
(EUCTR)
27/07/202117/08/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy - NA Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: [AMG 592]
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
5EUCTR2020-003509-72-GR
(EUCTR)
17/06/202122/04/2021A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
6EUCTR2020-003509-72-ES
(EUCTR)
17/06/202111/06/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
7EUCTR2020-003509-72-PL
(EUCTR)
21/05/202111/05/2021Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Efavaleukin Alfa
Product Code: AMG 592
INN or Proposed INN: EFAVALEUKIN ALFA
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan
8NCT04680637
(ClinicalTrials.gov)
May 6, 202118/12/2020Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care TherapyActive Systemic Lupus ErythematosusDrug: Efavaleukin Alfa;Drug: Placebo;Other: Standard of CareAmgenNULLRecruiting18 Years75 YearsAll320Phase 2United States;Austria;Bulgaria;Greece;Hong Kong;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Switzerland;Taiwan;Turkey
9JPRN-jRCT2041210076
06/05/202101/10/2021Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus ErythematosusA Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy Active Systemic Lupus ErythematosusPlacebo Comparator: Placebo + Standard of Care
Interventions: Drug: Placebo
Other: Standard of Care
Experimental: Efavaleukin Alfa Dose Level One + Standard of Care
Interventions: Drug: Efavaleukin Alfa
Other: Standard of Care
Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care
Interventions: Drug: Efavaleukin Alfa
Other: Standard of Care
Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care
Interventions: Drug: Efavaleukin Alfa
Other: Standard of Care
Hama YorikoNULLRecruiting>= 18age old<= 75age oldBoth320Phase 2United States;Korea, Republic of;Poland;Turkey;Greece,;Spain;Japan
10NCT03451422
(ClinicalTrials.gov)
April 10, 20181/2/2018Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Efavaleukin Alfa;Drug: PlaceboAmgenNULLCompleted18 Years70 YearsAll35Phase 1United States;France;Germany;Poland