49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | JPRN-jRCT2071210076 | 01/11/2021 | 15/10/2021 | A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC | Systemic Lupus Erythematosus | Approximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW). | Hibi Kazushige | NULL | Recruiting | >= 18age old | <= 70age old | Both | 36 | Phase 3 | United States;Argentina;Bulgaria;Chile;Colombia;Hungary;Mexico;Peru;Poland;Russia;Ukraine;United Kingdom;Germany;Spain;Japan |
| 2 | NCT04931563 (ClinicalTrials.gov) | September 13, 2021 | 29/4/2021 | Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: placebo | AstraZeneca | NULL | Recruiting | 18 Years | 70 Years | All | 328 | Phase 3 | China;Hong Kong;Korea, Republic of;Philippines;Taiwan;Thailand |
| 3 | EUCTR2020-004529-22-BG (EUCTR) | 10/09/2021 | 23/07/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) 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] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan | ||
| 4 | EUCTR2020-004529-22-HU (EUCTR) | 24/08/2021 | 18/06/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) 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] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Japan;Germany;Bulgaria;Peru;Poland;Argentina | ||
| 5 | NCT05001698 (ClinicalTrials.gov) | July 27, 2021 | 30/6/2021 | Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE) | A Phase I, Open-label, Single-Arm, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Anifrolumab in Chinese Participants With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Anifrolumab | AstraZeneca | NULL | Active, not recruiting | 18 Years | 60 Years | All | 15 | Phase 1 | China |
| 6 | NCT04750057 (ClinicalTrials.gov) | July 1, 2021 | 9/2/2021 | Anifrolumab Early Access Program | An Early Access Program for Anifrolumab Treatment in Adult Patients With Active Systemic Lupus Erythematosus - AMANA | Systemic Lupus Erythematosus | Drug: Anifrolumab | AstraZeneca | Clinigen, Inc. | No longer available | 18 Years | N/A | All | NULL | ||
| 7 | NCT04877691 (ClinicalTrials.gov) | June 8, 2021 | 4/5/2021 | Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Medi-546;Drug: Placebo | AstraZeneca | Iqvia Pty Ltd | Recruiting | 18 Years | 70 Years | All | 360 | Phase 3 | United States;Argentina;Bulgaria;Chile;Colombia;Germany;Hungary;Japan;Mexico;Peru;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 8 | NCT04726553 (ClinicalTrials.gov) | January 20, 2021 | 22/1/2021 | Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE | Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in Patients With Moderately to Severely Active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial: | Systemic Lupus Erythematosus (SLE) | Drug: Anifrolumab;Drug: Standard of Care | Oklahoma Medical Research Foundation | NYU Langone Health;Yale University;Piedmont Heart Institute, Inc., Atlanta, GA;Columbia University | Recruiting | 18 Years | 70 Years | All | 20 | Early Phase 1 | United States |
| 9 | 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 | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 10 | 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 | |
| 11 | 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 |
| 12 | EUCTR2016-003246-93-PL (EUCTR) | 26/01/2017 | 13/12/2016 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | ||
| 13 | 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: 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] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 14 | 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] | Product Name: Anifrolumab Product Code: MEDI-546 | Astrazeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Poland;Korea, Republic of | ||
| 15 | 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: 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] | 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;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | Completed | 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 |
| 19 | JPRN-JapicCTI-153064 | 27/4/2016 | 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 : Intravenous infusion (IV) Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Intravenous infusion (IV) | AstraZeneca | NULL | complete | 18 | 70 | BOTH | 60 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 20 | 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 | ||
| 21 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 27 | 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] | Product Name: Anifrolumab Product Code: NA INN or Proposed INN: Anifrolumab Product Name: Anifrolumab Product Code: NA INN or Proposed INN: Anifrolumab | ASTRAZENECA AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Korea, Republic of;New Zealand;Germany;Australia;Peru;Romania;Brazil;Poland;Argentina;Hungary;United Kingdom;Italy;Colombia;Israel;Chile;Ukraine;Taiwan;United States | ||
| 28 | 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] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 29 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 30 | 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] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 31 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 32 | 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 |
| 33 | 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 |
| 34 | 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] | 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 | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 35 | 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] | 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 | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Bulgaria;Korea, Republic of;Peru;Romania;Poland;Brazil;Mexico;Hungary;Czech Republic;Colombia;Ukraine;Taiwan;United States | ||
| 36 | EUCTR2012-004619-30-HU (EUCTR) | 27/08/2013 | 28/06/2013 | A Phase 2, Open-label Extension 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 | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of | ||
| 37 | 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 |
| 38 | 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 |