Soluble Fc-gamma receptor IIb ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス7

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
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2010-023396-25-PL
(EUCTR)
30/05/201223/09/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
2EUCTR2010-023396-25-NL
(EUCTR)
16/02/201224/10/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Germany;Netherlands;Italy;United Kingdom
3EUCTR2010-023396-25-DE
(EUCTR)
09/11/201114/06/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
4EUCTR2010-023396-25-CZ
(EUCTR)
13/10/201101/08/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
5EUCTR2010-023396-25-GB
(EUCTR)
22/09/201111/04/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
6EUCTR2010-023396-25-ES
(EUCTR)
20/09/201111/11/2011A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Poland;Australia
7EUCTR2010-023396-25-BE
(EUCTR)
13/07/201120/04/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Czech Republic;Spain;Poland;Belgium;Australia;Netherlands;Germany;Italy;United Kingdom