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
| 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 | EUCTR2020-003509-72-FR (EUCTR) | 21/10/2021 | 10/03/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 2 | EUCTR2020-003509-72-BG (EUCTR) | 31/08/2021 | 01/06/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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;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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 3 | EUCTR2020-003509-72-AT (EUCTR) | 12/08/2021 | 11/05/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of | ||
| 4 | EUCTR2020-003509-72-IT (EUCTR) | 27/07/2021 | 17/08/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus | 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 - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 5 | EUCTR2020-003509-72-GR (EUCTR) | 17/06/2021 | 22/04/2021 | 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 6 | EUCTR2020-003509-72-ES (EUCTR) | 17/06/2021 | 11/06/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 7 | EUCTR2020-003509-72-PL (EUCTR) | 21/05/2021 | 11/05/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 8 | NCT04082416 (ClinicalTrials.gov) | October 16, 2019 | 1/9/2019 | Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy | RemeGen Co., Ltd. | NULL | Active, not recruiting | 18 Years | 65 Years | All | 335 | Phase 3 | China |
| 9 | EUCTR2017-002564-40-DE (EUCTR) | 10/04/2018 | 04/12/2017 | Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 1;Phase 2 | United States;France;Poland;Germany | ||
| 10 | NCT02885610 (ClinicalTrials.gov) | December 2015 | 26/8/2016 | Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy | RemeGen | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | China |