Medi-546 (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 | 14 |
| 51 | 全身性強皮症 | 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 | EUCTR2016-000625-39-BG (EUCTR) | 17/05/2017 | 08/03/2017 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;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: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 2 | EUCTR2016-003246-93-PL (EUCTR) | 26/01/2017 | 13/12/2016 | The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer | Astrazeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | ||
| 3 | EUCTR2016-000625-39-LT (EUCTR) | 03/11/2016 | 17/08/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;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: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 4 | EUCTR2016-000625-39-ES (EUCTR) | 24/08/2016 | 15/07/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 19.0;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: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 5 | EUCTR2016-000625-39-HU (EUCTR) | 18/08/2016 | 23/06/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;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: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 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 | EUCTR2012-004619-30-BG (EUCTR) | 09/05/2014 | 07/03/2014 | A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus | A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus | 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: Diseases [C] - Immune System Diseases [C20] | MedImmune, LLC, a wholly owned subsidiary of AstraZeneca | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of | |||
| 7 | EUCTR2012-004619-30-CZ (EUCTR) | 29/08/2013 | 19/06/2013 | A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus | A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;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] | MedImmune, LLC, a wholly owned subsidiary of AstraZeneca | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of | |||
| 8 | EUCTR2012-004619-30-HU (EUCTR) | 27/08/2013 | 28/06/2013 | A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus | A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus | 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: Diseases [C] - Immune System Diseases [C20] | Product Name: anifrolumab Product Code: Medi-546 INN or Proposed INN: anifrolumab Product Name: anifrolumab Product Code: Medi-546 INN or Proposed INN: anifrolumab | MedImmune, LLC, a wholly owned subsidiary of AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 9 | EUCTR2011-004296-36-BG (EUCTR) | 10/06/2013 | 14/03/2013 | NA | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects 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: MEDI-546 Product Code: MEDI-546 INN or Proposed INN: MEDI-546 | MedImmune, LLC | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Taiwan;Hong Kong;Ukraine;Colombia;India;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 10 | NCT01753193 (ClinicalTrials.gov) | March 28, 2013 | 17/12/2012 | An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults | A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: Anifrolumab | MedImmune LLC | NULL | Completed | 18 Years | 68 Years | All | 218 | Phase 2 | United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic |
| 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 | EUCTR2011-004296-36-HU (EUCTR) | 22/01/2013 | 29/11/2012 | A Study to evaluate the efficacy and safety of MEDI-546 compared toplacebo in subjects with Systemic Lupus Erythematosus | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 17.0;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: MEDI-546 Product Code: MEDI-546 INN or Proposed INN: MEDI-546 | MedImmune, LLC | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Taiwan;Hong Kong;Ukraine;Colombia;India;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 12 | EUCTR2011-004296-36-CZ (EUCTR) | 29/08/2012 | 28/06/2012 | A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus Erythematosus | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 17.0;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: MEDI-546 Product Code: MEDI-546 INN or Proposed INN: MEDI-546 | MedImmune, LLC | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Taiwan;Hong Kong;Ukraine;Israel;Colombia;India;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 13 | NCT01559090 (ClinicalTrials.gov) | April 20, 2012 | 19/3/2012 | Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus. | A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Drug: MEDI-546 | AstraZeneca | MedImmune LLC | Completed | 18 Years | 65 Years | All | 17 | Phase 2 | Japan |
| 14 | NCT01438489 (ClinicalTrials.gov) | January 2012 | 9/9/2011 | A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | 65 Years | All | 626 | Phase 2 | United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong |
| 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 | NCT00930683 (ClinicalTrials.gov) | September 2009 | 29/6/2009 | A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma | A Phase 1 Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor, in Adult Subjects With Scleroderma | Scleroderma | Drug: MEDI-546 | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 34 | Phase 1 | United States |