Sm101    (DrugBank: -)

3 diseases
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
63特発性血小板減少性紫斑病3
66IgA腎症2

49. 全身性エリテマトーデス [臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 827 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-023396-25-PL30/05/201223/09/2011A 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: 15.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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-NL16/02/201224/10/2011A 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: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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-DE09/11/201114/06/2011A 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: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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-CZ13/10/201101/08/2011A 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: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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-GB22/09/201111/04/2011A 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: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2010-023396-25-ES20/09/201111/11/2011A 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: 14.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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-BE13/07/201120/04/2011A 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: 13.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem 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

63. 特発性血小板減少性紫斑病 [臨床試験数:311,薬物数:185(DrugBank:39),標的遺伝子数:43,標的パスウェイ数:132
Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
3 / 311 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-014842-28-PL21/01/201002/10/2009A study to assess the safety and effectiveness of the study drug(SM101) versus placebo( dummy treatment)in adult patients with chronic Primary Immune Thrombocytopenia(ITP)A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP). Primary Immune Thrombocytopenia
MedDRA version: 15.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SM101 20mg/mL
Product Code: SM101
INN or Proposed INN: SM101
Product Name: SM101 5mg/mL
Product Code: SM101
INN or Proposed INN: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
69Phase 1Belgium;Poland;Ukraine;Russian Federation;Germany
2EUCTR2009-014842-28-DE14/01/201021/09/2009A study to assess the safety and effectiveness of the study drug (SM101) versus a placebo (dummy treatment) in adult patients with chronic Primary Immune Thrombocytopenia (ITP).A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP). Primary Immune Thrombocytopenia
MedDRA version: 14.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SM101 20mg/mL
Product Code: SM101
INN or Proposed INN: SM101
Product Name: SM101 5mg/mL
Product Code: SM101
INN or Proposed INN: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
69Phase 1Belgium;Poland;Ukraine;Russian Federation;Germany
3EUCTR2009-014842-28-BE06/01/201014/09/2009A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Idiopathic Thrombocytopenic Purpura (ITP).A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Idiopathic Thrombocytopenic Purpura (ITP). Idiopathic Thrombocytopenic Purpura
MedDRA version: 12.0Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: SM101
Product Code: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
51Phase 1;Phase 2Poland;Belgium;Germany

66. IgA腎症 [臨床試験数:199,薬物数:214(DrugBank:57),標的遺伝子数:32,標的パスウェイ数:128
Searched query = "IgA nephropathy", "IgA nephritis", "Berger disease", "IgA-IgG nephropathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 199 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02605525December 201512/11/2015Efficacy and Safety of SM101 in the Treatment of IgA NephropathyA Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN)Immunoglobulin A NephropathyBiological: SM101;Other: PlaceboBaxalta now part of ShireNULLWithdrawn18 YearsN/AAll0Phase 2NULL
2EUCTR2015-002345-64-CZ12/11/201508/09/2015Efficacy and Safety of SM101 in the Treatment of IgA NephropathyA Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion with Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy IgA Nephropathy
MedDRA version: 18.0Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: SM101
INN or Proposed INN: Not available
Other descriptive name: human soluble recombinant Fc-gamma receptor IIB
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
51Phase 2United States;Hong Kong;Czech Republic;Canada;Belgium;Denmark;Germany;United Kingdom;Sweden