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 | NCT01953835 (ClinicalTrials.gov) | October 4, 2013 | 26/9/2013 | A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 | A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184 | Systemic Lupus Erythematosus | Drug: GSK2586184 standard formulation;Drug: Simvastatin;Drug: Rosuvastatin;Drug: GSK2586184 new formulation | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 1 | United States |
| 2 | EUCTR2012-001645-41-CZ (EUCTR) | 15/04/2013 | 05/12/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. | Systemic Lupus Erythematosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Estonia;Hong Kong;Greece;Spain;Thailand;Chile;Russian Federation;India;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of | ||
| 3 | EUCTR2012-001645-41-PL (EUCTR) | 14/03/2013 | 20/12/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. | Systemic Lupus Erythematosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Hong Kong;Estonia;Greece;Thailand;Spain;Chile;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Germany;Korea, Republic of;Sweden | ||
| 4 | NCT01777256 (ClinicalTrials.gov) | March 1, 2013 | 24/1/2013 | An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 | An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 75 Years | All | 51 | Phase 2 | Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic |
| 5 | EUCTR2012-001645-41-DE (EUCTR) | 19/02/2013 | 16/10/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. | Systemic Lupus Erythematosus MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of;Thailand;Russian Federation;Chile;Estonia;Hong Kong;Greece;Spain | ||
| 6 | EUCTR2012-001645-41-SE (EUCTR) | 15/02/2013 | 29/10/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. | Systemic Lupus Erythematosus 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] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of | ||
| 7 | EUCTR2012-001645-41-EE (EUCTR) | 28/12/2012 | 27/11/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. | Systemic Lupus Erythematosus MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Estonia;Hong Kong;Greece;Spain;Chile;Czech Republic;Hungary;Argentina;Poland;Brazil;Peru;South Africa;Germany;Korea, Republic of;Sweden | ||
| 8 | EUCTR2012-001645-41-ES (EUCTR) | 19/12/2012 | 12/11/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. | Systemic Lupus Erythematosus 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] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of | ||
| 9 | EUCTR2012-001645-41-HU (EUCTR) | 13/12/2012 | 24/10/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. | Systemic Lupus Erythematosus 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] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of | ||
| 10 | EUCTR2012-001645-41-GR (EUCTR) | 11/12/2012 | 13/11/2012 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. | Systemic Lupus Erythematosus 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] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Product Name: GSK2586184 Product Code: GSK2586184 INN or Proposed INN: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of | ||
| 11 | NCT01687309 (ClinicalTrials.gov) | April 30, 2012 | 10/5/2012 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects | Systemic Lupus Erythematosus | Drug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without food | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 19 | Phase 1 | Belgium |