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

  
36 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
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PhaseCountries
1EUCTR2018-004645-16-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
2EUCTR2018-004645-16-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
3EUCTR2018-004645-16-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
4EUCTR2016-003050-32-NL
(EUCTR)
16/02/201824/10/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (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 Erythematosus (SLE) or Lupus
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: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of
5EUCTR2016-003050-32-DE
(EUCTR)
09/01/201821/06/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) Systemic Lupus Erythematosus (SLE) or Lupus
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: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
6EUCTR2016-003050-32-ES
(EUCTR)
05/12/201701/12/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered 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 Erythematosus (SLE) or Lupus
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: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Argentina;Brazil;Spain;South Africa;Russian Federation;Netherlands;Germany;Korea, Republic of
7EUCTR2007-007648-85-AT
(EUCTR)
21/01/201009/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;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]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
8EUCTR2007-007648-85-FR
(EUCTR)
08/09/200917/07/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1620 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
9EUCTR2007-007648-85-SE
(EUCTR)
26/08/200903/06/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;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]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 1;Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
10EUCTR2007-007648-85-SK
(EUCTR)
28/07/200924/06/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term:
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B
Human Genome Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1620Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
11EUCTR2007-007648-85-BE
(EUCTR)
01/07/200905/01/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;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]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
12EUCTR2007-007648-85-IT
(EUCTR)
03/06/200920/04/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
Product Name: Belimumab
Product Code: HGS1006
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
1620Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
13EUCTR2007-007648-85-ES
(EUCTR)
27/04/200925/02/2009A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057 Systemic lupus erythematosus (SLE)Lupus Eritematoso Sistémico (LES)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
14EUCTR2007-007648-85-NL
(EUCTR)
07/04/200919/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;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 400 mg powder for concentrate for solution for infusions
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B; Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Germany;Netherlands;Sweden;Korea, Republic of
15EUCTR2007-007648-85-CZ
(EUCTR)
01/04/200926/01/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 16.1;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: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
16EUCTR2007-007648-85-GB
(EUCTR)
13/03/200919/01/2009A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.0;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]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
1620 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
17EUCTR2007-007648-85-DE
(EUCTR)
06/02/200903/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;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]
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
18NCT00732940
(ClinicalTrials.gov)
October 20088/8/2008Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Belimumab 100 mg SCHuman Genome Sciences Inc.GlaxoSmithKlineTerminated18 YearsN/AAll56Phase 2United States;Mexico
19NCT00724867
(ClinicalTrials.gov)
August 200828/7/2008A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United StatesA Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United StatesSystemic Lupus ErythematosusBiological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kgHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll268Phase 3United States;Canada
20NCT00712933
(ClinicalTrials.gov)
May 30, 20088/7/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Systemic Lupus ErythematosusDrug: belimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll738Phase 3Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czechia;France;Germany;Hong Kong;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;United Kingdom;Australia;China;Costa Rica;Czech Republic
21EUCTR2006-005177-21-AT
(EUCTR)
06/12/200726/02/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
22EUCTR2006-005177-21-IT
(EUCTR)
20/09/200713/07/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056 Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Belimumab
Product Code: HGS1006
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
23EUCTR2006-005177-21-FR
(EUCTR)
11/09/200723/07/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
24EUCTR2006-005177-21-NL
(EUCTR)
03/08/200704/06/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
25EUCTR2006-005177-21-SE
(EUCTR)
08/06/200707/05/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
26EUCTR2006-005177-21-GB
(EUCTR)
29/05/200702/01/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
810 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
27EUCTR2006-005177-21-SK
(EUCTR)
17/05/200720/03/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
28EUCTR2006-005177-21-ES
(EUCTR)
09/05/200709/03/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76 Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
29EUCTR2006-005177-21-BE
(EUCTR)
07/05/200729/01/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
30EUCTR2006-005177-21-DE
(EUCTR)
03/05/200720/02/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
31NCT00424476
(ClinicalTrials.gov)
May 200717/1/2007A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.GlaxoSmithKlineCompleted18 YearsN/AAll865Phase 3Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China
32EUCTR2006-005177-21-CZ
(EUCTR)
23/04/200728/02/2007A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM
Human Genome Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
810Phase 3Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
33NCT00410384
(ClinicalTrials.gov)
December 20068/12/2006A Study of Belimumab in Subjects With Systemic Lupus ErythematosusA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.GlaxoSmithKlineCompleted18 YearsN/AAll819Phase 3United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom
34NCT00583362
(ClinicalTrials.gov)
May 4, 200520/12/2007A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02Systemic Lupus ErythematosusBiological: BelimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll298Phase 2United States;Canada
35NCT00071487
(ClinicalTrials.gov)
October 200324/10/2003Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.NULLCompleted18 Years65 YearsAll449Phase 2United States;Canada
36NCT00657007
(ClinicalTrials.gov)
February 20028/4/2008Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: belimumab;Biological: PlaceboHuman Genome Sciences Inc.NULLCompleted18 YearsN/ABoth70Phase 1United States