49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details


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

  
20 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-004529-22-DE
(EUCTR)
21/04/202223/09/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA 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
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
2EUCTR2020-004529-22-BG
(EUCTR)
10/09/202123/07/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA 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
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
3EUCTR2020-004529-22-HU
(EUCTR)
24/08/202118/06/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA 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
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
4NCT04877691
(ClinicalTrials.gov)
June 8, 20214/5/2021Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Medi-546;Drug: PlaceboAstraZenecaIqvia Pty LtdRecruiting18 Years70 YearsAll360Phase 3United States;Argentina;Bulgaria;Chile;Colombia;Germany;Hungary;Japan;Mexico;Peru;Poland;Russian Federation;Spain;Ukraine;United Kingdom
5EUCTR2016-000625-39-BG
(EUCTR)
17/05/201708/03/2017A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA 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 ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United 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
6EUCTR2016-003246-93-PL
(EUCTR)
26/01/201713/12/2016A 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 ABNULLNot RecruitingFemale: yes
Male: yes
32Phase 2United States;Hungary;Poland;Korea, Republic of
7EUCTR2016-000625-39-DE
(EUCTR)
13/12/201605/07/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA 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 ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United 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
8EUCTR2016-003246-93-HU
(EUCTR)
06/12/201619/10/2016 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 ABNULLNot 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): noUnited States;Hungary;Poland;Korea, Republic of
9EUCTR2016-000625-39-LT
(EUCTR)
03/11/201617/08/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA 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 ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3South Africa;Korea, Republic of;Lithuania;United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
10EUCTR2016-000625-39-ES
(EUCTR)
24/08/201615/07/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United 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
11EUCTR2016-000625-39-HU
(EUCTR)
18/08/201623/06/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA 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 ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
12EUCTR2012-004619-30-BG
(EUCTR)
09/05/201407/03/2014A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA 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 AstraZenecaNULLNot 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): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
13EUCTR2012-004619-30-CZ
(EUCTR)
29/08/201319/06/2013A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA 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 AstraZenecaNULLNot 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): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
14EUCTR2012-004619-30-HU
(EUCTR)
27/08/201328/06/2013A 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 AstraZenecaNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
15EUCTR2011-004296-36-BG
(EUCTR)
10/06/201314/03/2013NAA 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,NULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Taiwan;Hong Kong;Ukraine;Colombia;India;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
16NCT01753193
(ClinicalTrials.gov)
March 28, 201317/12/2012An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in AdultsA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: AnifrolumabMedImmune LLCNULLCompleted18 Years68 YearsAll218Phase 2United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic
17EUCTR2011-004296-36-HU
(EUCTR)
22/01/201329/11/2012A Study to evaluate the efficacy and safety of MEDI-546 compared toplacebo in subjects with Systemic Lupus ErythematosusA 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,NULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Taiwan;Hong Kong;Ukraine;Colombia;India;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
18EUCTR2011-004296-36-CZ
(EUCTR)
29/08/201228/06/2012A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus ErythematosusA 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,NULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Taiwan;Hong Kong;Ukraine;Israel;Colombia;India;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
19NCT01559090
(ClinicalTrials.gov)
April 20, 201219/3/2012Safety 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 ErythematosusDrug: MEDI-546AstraZenecaMedImmune LLCCompleted18 Years65 YearsAll17Phase 2Japan
20NCT01438489
(ClinicalTrials.gov)
January 20129/9/2011A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus ErythematosusA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: PlaceboMedImmune LLCNULLCompleted18 Years65 YearsAll626Phase 2United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong