RECOMBINANT FACTOR FC FUSION PROTEIN ( DrugBank: - )


2 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2
49全身性エリテマトーデス8

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
1EUCTR2017-001944-36-ES
(EUCTR)
21/05/201810/10/2017Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: AMG592
INN or Proposed INN: AMG 592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
137Phase 1;Phase 2United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
2EUCTR2017-001944-36-BG
(EUCTR)
13/03/201824/10/2017Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: AMG592
INN or Proposed INN: N/A
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
153Phase 1;Phase 2United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
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 2Russian Federation;Chile;Colombia;Italy;Switzerland;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of;Spain;Turkey;Austria;United States;Hong Kong;Taiwan;Greece
8EUCTR2017-002564-40-DE
(EUCTR)
10/04/201804/12/2017Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus ErythematosusA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy. 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: AMG592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 1;Phase 2United States;France;Poland;Germany