Anifrolumab (DrugBank: Anifrolumab)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 2 |
| 49 | 全身性エリテマトーデス | 28 |
| 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 | NCT03435601 (ClinicalTrials.gov) | April 18, 2018 | 31/1/2018 | A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA) | A Randomised, Double-blind, Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA) | Rheumatoid Arthritis | Drug: Anifrolumab;Drug: Placebos | Josef Smolen, Univ. Prof. Dr. | NULL | Recruiting | 18 Years | 70 Years | All | 24 | Phase 2 | Austria |
| 2 | EUCTR2017-001717-92-AT (EUCTR) | 11/12/2017 | 17/08/2017 | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA) | A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA | High IFN siganture in patients with rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab (MEDI-546) INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | Medical University of Vienna | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Austria;Switzerland;Italy |
| 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 | JPRN-JapicCTI-173544 | 26/4/2017 | 23/03/2017 | TULIP SLE LTE | 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 | Active Systemic Lupus Erythematosus | Intervention name : Anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses | AstraZeneca | NULL | complete | 18 | BOTH | 50 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 3 | NCT02962960 (ClinicalTrials.gov) | February 14, 2017 | 23/9/2016 | A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations | 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 | Drug: Anifrolumab;Drug: Placebo | AstraZeneca | NULL | Completed | 18 Years | 70 Years | All | 36 | Phase 2 | United States;Hungary;Korea, Republic of;Poland |
| 4 | 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 | ||
| 5 | EUCTR2016-000625-39-DE (EUCTR) | 13/12/2016 | 05/07/2016 | 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: 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] | 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 | |||
| 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 | EUCTR2016-003246-93-HU (EUCTR) | 06/12/2016 | 19/10/2016 | 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] | Astrazeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | |||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | NCT02794285 (ClinicalTrials.gov) | June 30, 2016 | 6/6/2016 | Long Term Safety of Anifrolumab in Adult Subjects With Active 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. | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Active, not recruiting | 18 Years | 70 Years | All | 559 | Phase 3 | United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore |
| 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 | EUCTR2014-004632-19-BG (EUCTR) | 11/12/2015 | 27/10/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active 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] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 12 | EUCTR2014-004633-96-RO (EUCTR) | 26/11/2015 | 08/10/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active 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] | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | |||
| 13 | EUCTR2014-004633-96-DE (EUCTR) | 12/11/2015 | 28/05/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | 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 INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of | ||
| 14 | EUCTR2014-004632-19-DE (EUCTR) | 12/11/2015 | 06/08/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active 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] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 15 | EUCTR2014-004633-96-PL (EUCTR) | 14/10/2015 | 05/08/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active 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] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of | ||
| 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 |
| 16 | EUCTR2014-004632-19-CZ (EUCTR) | 23/09/2015 | 28/07/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active 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 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 17 | EUCTR2014-004632-19-ES (EUCTR) | 21/09/2015 | 24/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active 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] | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | |||
| 18 | EUCTR2014-004633-96-IT (EUCTR) | 16/09/2015 | 21/01/2020 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA | Systemic Lupus Erythematosus MedDRA version: 21.1;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] | ASTRAZENECA AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | |||
| 19 | EUCTR2014-004632-19-BE (EUCTR) | 07/09/2015 | 23/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active 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] | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | |||
| 20 | EUCTR2014-004633-96-HU (EUCTR) | 02/09/2015 | 29/06/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active 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] | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | |||
| 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 |
| 21 | EUCTR2014-004632-19-LT (EUCTR) | 20/08/2015 | 19/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active 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] | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | |||
| 22 | EUCTR2014-004633-96-GB (EUCTR) | 16/07/2015 | 08/05/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active 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] | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | |||
| 23 | NCT02446899 (ClinicalTrials.gov) | July 9, 2015 | 14/5/2015 | Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 373 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore |
| 24 | NCT02446912 (ClinicalTrials.gov) | June 9, 2015 | 14/5/2015 | Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 460 | Phase 3 | United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom |
| 25 | 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 | ||
| 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | JPRN-JapicCTI-153064 | 11/11/2015 | TULIP | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses Control intervention name : Placebo Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses | AstraZeneca | NULL | complete | 18 | 70 | BOTH | Phase 3 | NULL |