EPRATUZUMAB ( DrugBank: Epratuzumab )
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 | 57 |
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
Showing 1 to 10 of 57 diseases
| 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 | NCT02306629 (ClinicalTrials.gov) | November 2014 | 29/11/2014 | Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood Study to Compare Properties of EpratuzumabWhen Given as an Injection Under the Skin or Directly Into ... | An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety ... | Systemic Lupus Erythematosus | Biological: Epratuzumab sc;Biological: Epratuzumab iv | UCB Biopharma S.P.R.L. | Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors Laboratory Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma B ... | Completed | 18 Years | 50 Years | Both | 42 | Phase 1 | United Kingdom |
| 2 | EUCTR2010-020859-30-IT (EUCTR) | 23/06/2012 | 06/03/2012 | Open-label study of long-term Epratuzumab treatment in subjects withSystemic Lupus Erythematosus (SLE) Open-label study of long-term Epratuzumabtreatment in subjects withSystemic Lupus Erythematosus (SLE ... | A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratu ... | 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] - Immune system processes [G12] Systemic lupus erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Syste ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB Other descriptive name: NA Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB Other descriptive name ... | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Bulgaria;South Africa;Germany;Korea, Republic of United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Lithuania;Russian Federation;Israel;United King ... | ||
| 3 | EUCTR2010-020859-30-EE (EUCTR) | 15/06/2012 | 04/06/2012 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) Open-label study of long-term Epratuzumabtreatment in subjects with Systemic Lupus Erythematosus (SL ... | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuz ... | Systemic Lupus Erythematosus MedDRA version: 18.0;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] Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Syste ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australi ... | ||
| 4 | EUCTR2010-018563-41-EE (EUCTR) | 09/04/2012 | 09/03/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) Study of Epratuzumabversus Placebo in subjects with moderate to severe general Systemic Lupus Erythe ... | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safet ... | Systemic Lupus Erythmatosus MedDRA version: 17.0;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] Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: System ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;M ... | ||
| 5 | EUCTR2010-018563-41-LT (EUCTR) | 14/03/2012 | 14/02/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) Study of Epratuzumabversus Placebo in subjects with moderate to severe general Systemic Lupus Erythe ... | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safet ... | Systemic Lupus Erythmatosus MedDRA version: 17.0;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] Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: System ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;M ... | ||
| 6 | NCT01534403 (ClinicalTrials.gov) | January 2012 | 13/2/2012 | Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects | A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of EpratuzumabTr ... | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | NULL | Completed | 18 Years | 65 Years | Both | 17 | Phase 2 | Japan |
| 7 | EUCTR2010-020859-30-BG (EUCTR) | 18/11/2011 | 18/07/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) Open-label study of long-term Epratuzumabtreatment in subjects with Systemic Lupus Erythematosus (SL ... | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuz ... | Systemic Lupus Erythematosus MedDRA version: 18.0;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] Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Syste ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany United States;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australi ... | ||
| 8 | EUCTR2010-020859-30-LT (EUCTR) | 10/10/2011 | 11/08/2011 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) Open-label study of long-term Epratuzumabtreatment in subjects with Systemic Lupus Erythematosus (SL ... | A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 A phase 3, multicenter, open-label, extension study to assess the safety and tolerability of Epratuz ... | Systemic Lupus Erythematosus MedDRA version: 18.0;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] Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Syste ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australi ... | ||
| 9 | NCT01449071 (ClinicalTrials.gov) | October 2011 | 3/10/2011 | Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Study Evaluating the Pharmacokinetics and Safety of Epratuzumabin Japanese Systemic Lupus Erythemato ... | A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the S ... | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mg Biological: Placebo;Biological: Epratuzumab400 mg;Biological: Epratuzumab1200 mg;Biological: Epratuz ... | UCB Pharma | NULL | Completed | 18 Years | 64 Years | Both | 20 | Phase 1/Phase 2 | Japan |
| 10 | EUCTR2010-018565-26-IT (EUCTR) | 15/09/2011 | 05/01/2012 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) Study of Epratuzumabversus Placebo in subjects with moderate to severe general Systemic Lupus Erythe ... | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFET ... | Systemic Lupus Erythmatosus 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] Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: System ... | Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;It ... |