49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
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. | 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 | EUCTR2010-023396-25-PL (EUCTR) | 30/05/2012 | 23/09/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2010-023396-25-NL (EUCTR) | 16/02/2012 | 24/10/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Germany;Netherlands;Italy;United Kingdom | ||
| 3 | EUCTR2010-023396-25-DE (EUCTR) | 09/11/2011 | 14/06/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2010-023396-25-CZ (EUCTR) | 13/10/2011 | 01/08/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2010-023396-25-GB (EUCTR) | 22/09/2011 | 11/04/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2010-023396-25-ES (EUCTR) | 20/09/2011 | 11/11/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Ensayo clínico multicéntrico, de grupos paralelos, controlado por placebo, doble ciego, randomizado 2:2:1, de fase IIa, para investigar la seguridad, eficacia y farmacocinética del receptor Fc-gamma IIb recombinante, humano, soluble (SM101) para su aplicación intravenosa en el tratamiento de pacientes con lupus eritematoso sistémico (LES) con o sin un historial de nefritis lúpica - SMILE | lupus eritematoso sistémico (LES) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Poland;Australia | |||
| 7 | EUCTR2010-023396-25-BE (EUCTR) | 13/07/2011 | 20/04/2011 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Other descriptive name: soluble Fc receptor | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Czech Republic;Spain;Poland;Belgium;Australia;Netherlands;Germany;Italy;United Kingdom |