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

  
22 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05247203
(ClinicalTrials.gov)
May 17, 202226/1/2022Telitacicept Study in Chinese Subjects With Systemic Lupus ErythematosusA Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Telitacicept;Drug: standard therapyRemeGen Co., Ltd.NULLRecruiting18 Years65 YearsAll75Phase 1China
2JPRN-jRCT2071210076
03/03/202215/10/2021A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusThe 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 ErythematosusApproximately 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 KazushigeNULLRecruiting>= 18age old<= 70age oldBoth36Phase 3United States;Argentina;Bulgaria;Chile;Colombia;Hungary;Mexico;Peru;Poland;Russia;Ukraine;United Kingdom;Germany;Spain;Japan
3ChiCTR2100052342
2021-12-012021-10-24A clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injectionA clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injection systemic lupus erythematosusstandard treatment group:standard treatment ;Belimumab + standard therapy group 1:Belimumab(5mg/kg.m)+ standard therapy;Belimumab + standard therapy group 2:Belimumab(10mg/kg.m)+standard therapy;Belimumab + standard of care group 3:Belimumab(10mg/kg.2m)+standard of care group;Affiliated Hospital of Guilin Medical CollegeNULLRecruiting1665Bothstandard treatment group:25;Belimumab + standard therapy group 1:25;Belimumab + standard therapy group 2:25;Belimumab + standard of care group 3:25;Phase 4China
4NCT04908865
(ClinicalTrials.gov)
October 21, 202126/5/2021Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Belimumab;Drug: Standard therapyGlaxoSmithKlineNULLRecruiting5 Years17 YearsAll65Phase 4China
5EUCTR2018-004645-16-NL
(EUCTR)
29/01/202029/10/2019A study of belimumab in children with lupusA Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE Lupus - 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: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan
6EUCTR2018-004645-16-DE
(EUCTR)
27/12/201918/09/2019A study of belimumab in children with lupusA Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE Lupus - 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: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
7EUCTR2018-004645-16-ES
(EUCTR)
16/12/201911/11/2019A study of belimumab in children with lupusA Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE Lupus - 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: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
8NCT04179032
(ClinicalTrials.gov)
November 28, 201925/11/2019Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusCombination Product: BelimumabGlaxoSmithKlineNULLActive, not recruiting5 Years17 YearsAll30Phase 2United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain
9NCT04082416
(ClinicalTrials.gov)
October 16, 20191/9/2019Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapyRemeGen Co., Ltd.NULLActive, not recruiting18 Years65 YearsAll335Phase 3China
10NCT03312907
(ClinicalTrials.gov)
March 1, 201813/10/2017A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid TaperGlaxoSmithKlineNULLCompleted18 YearsN/AAll292Phase 3United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
11NCT02885610
(ClinicalTrials.gov)
December 201526/8/2016Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapyRemeGenNULLCompleted18 Years65 YearsAll249Phase 2China
12NCT01632241
(ClinicalTrials.gov)
February 19, 201328/6/2012Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll503Phase 4United States;Brazil;Colombia;France;South Africa;United Kingdom
13EUCTR2011-000368-88-IT
(EUCTR)
04/02/201311/12/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age.A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE 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]
Trade Name: Benlysta (belimumab)
INN or Proposed INN: BELIMUMAB
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
100United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy
14EUCTR2011-000368-88-NL
(EUCTR)
03/12/201202/07/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 17.1;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]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom
15NCT01705977
(ClinicalTrials.gov)
November 27, 201210/10/2012Belimumab Assessment of Safety in SLEA Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving BelimumabSystemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapyGlaxoSmithKlineNULLCompleted18 YearsN/AAll4019Phase 4United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway
16NCT01649765
(ClinicalTrials.gov)
September 7, 201223/7/2012Pediatric Lupus Trial of Belimumab Plus Background Standard TherapyA Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: belimumab 10mg/kg;Other: placeboGlaxoSmithKlineHuman Genome Sciences Inc., a GSK CompanyActive, not recruiting5 Years17 YearsAll93Phase 2United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;Italy;Netherlands
17EUCTR2011-000368-88-ES
(EUCTR)
27/07/201221/05/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age.A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE 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]
Trade Name: BENLYSTA? (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland
18EUCTR2011-000368-88-GB
(EUCTR)
13/06/201218/04/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE 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]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom
19NCT01484496
(ClinicalTrials.gov)
November 16, 201128/11/2011A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll839Phase 3United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
20NCT00479622
(ClinicalTrials.gov)
August 200725/5/2007Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusA Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: TRU-015Wyeth is now a wholly owned subsidiary of PfizerEmergent Product Development Seattle LLCTerminated18 Years70 YearsBoth20Phase 1United States
21EUCTR2011-000368-88-Outside-EU/EEA
(EUCTR)
17/02/2014A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE Systemic Lupus Erythematosus
MedDRA version: 16.1;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]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLNAFemale: yes
Male: yes
100Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States
22EUCTR2011-000368-88-PL
(EUCTR)
04/06/2012A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of ageA Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with SLE - Belimumab in pediatric patients with SLE 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]
Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom