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 |
| 66 | IgA腎症 | 2 |
| 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 2a | 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 2a | 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 2a | 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 2a | 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 | ||
| 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 |
| 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 |
| 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 | EUCTR2009-014842-28-PL (EUCTR) | 21/01/2010 | 02/10/2009 | A 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: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase Ib/2a | Belgium;Poland;Ukraine;Russian Federation;Germany | ||
| 2 | EUCTR2009-014842-28-DE (EUCTR) | 14/01/2010 | 21/09/2009 | A 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: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase Ib/2a | Belgium;Poland;Ukraine;Russian Federation;Germany | ||
| 3 | EUCTR2009-014842-28-BE (EUCTR) | 06/01/2010 | 14/09/2009 | 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). | 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: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: SM101 Product Code: SM101 | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 1;Phase 2 | Poland;Belgium;Germany |
| 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 | NCT02605525 (ClinicalTrials.gov) | December 2015 | 12/11/2015 | Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy | A 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 Nephropathy | Biological: SM101;Other: Placebo | Baxalta now part of Shire | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | NULL |
| 2 | EUCTR2015-002345-64-CZ (EUCTR) | 12/11/2015 | 08/09/2015 | Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy | A 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: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2 | United States;Hong Kong;Czech Republic;Canada;Belgium;Denmark;Germany;United Kingdom;Sweden |