Medi-545 (DrugBank: -)
2 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 | 12 |
| 50 | 皮膚筋炎／多発性筋炎 | 1 |
| 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 | EUCTR2010-024069-30-BG (EUCTR) | 21/08/2012 | 08/08/2012 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with 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: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2b | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Netherlands;Germany | ||
| 2 | EUCTR2010-024069-30-DE (EUCTR) | 21/12/2011 | 19/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with 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: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2b | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany | ||
| 3 | EUCTR2010-024069-30-NL (EUCTR) | 05/08/2011 | 04/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 544 | Phase 2b | Hungary;Germany;Netherlands;France;Chile;Italy;South Africa;Brazil;India;United Kingdom;Canada;Peru;Mexico;Argentina;Romania;Spain;Thailand;United States;Philippines;Poland | ||
| 4 | EUCTR2010-024069-30-IT (EUCTR) | 05/07/2011 | 19/01/2012 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with 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: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 544 | Phase 2b | United States;Philippines;Spain;Thailand;Chile;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Brazil;Peru;Bulgaria;South Africa;Germany;Netherlands | ||
| 5 | EUCTR2010-024069-30-ES (EUCTR) | 19/05/2011 | 19/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 544 | Phase 2b | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Netherlands | ||
| 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 | EUCTR2010-024069-30-GB (EUCTR) | 18/05/2011 | 13/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with 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: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Romania;Peru;Bulgaria;South Africa;Netherlands;Germany;Brazil;United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland | ||
| 7 | NCT00979654 (ClinicalTrials.gov) | August 2010 | 17/9/2009 | A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis | A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis | Systemic Lupus Erythematosus | Drug: Sifalimumab | MedImmune LLC | PPD | Completed | 18 Years | 99 Years | All | 118 | Phase 2 | United States;Brazil;Canada;Chile |
| 8 | NCT01031836 (ClinicalTrials.gov) | November 25, 2009 | 11/12/2009 | A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus. | A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: MEDI-545;Drug: MEDI-545 600 | AstraZeneca | MedImmune LLC | Completed | 20 Years | 130 Years | All | 30 | Phase 2 | Japan |
| 9 | NCT00657189 (ClinicalTrials.gov) | July 2008 | 9/4/2008 | A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus | A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus | Drug: MEDI-545;Drug: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 87 | Phase 2 | United States |
| 10 | NCT00482989 (ClinicalTrials.gov) | June 2007 | 4/6/2007 | A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus | A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Systemic Lupus Erythematosus | Lupus | Biological: MEDI 545;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 183 | Phase 1 | United States;Argentina;Brazil;Chile;Canada |
| 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 |
| 11 | NCT00299819 (ClinicalTrials.gov) | March 2006 | 6/3/2006 | Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE) | A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE) | Lupus | Biological: MEDI-545;Biological: MEDI 545 | MedImmune LLC | NULL | Completed | 18 Years | 80 Years | Both | 45 | Phase 1 | United States;Canada |
| 12 | EUCTR2010-024069-30-HU (EUCTR) | 17/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with 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: Diseases [C] - Immune System Diseases [C20] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2b | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;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 | NCT00533091 (ClinicalTrials.gov) | April 2008 | 20/9/2007 | A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis | A Phase 1B, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Safety of Multiple-Dose, Intravenously Administered MEDI-545, A Fully Human Anti Interferon-Alpha Monoclonal Antibody, In Adult Patients With Dermatomyositis or Polymyositis | DERMATOMYOSITIS OR POLYMYOSITIS | Biological: MEDI-545;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 51 | Phase 1 | United States |