Benlysta® ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
49Systemic lupus erythematosus7
222Primary nephrotic syndrome5

49. Systemic lupus erythematosus


Clinical trials : 946 Drugs : 722 - (DrugBank : 186) / Drug target genes : 117 - Drug target pathways : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001802-30-DE
(EUCTR)
28/10/202102/09/2021Efficacy of the drug Benlysta (active ingredient: belimumab) to improve cardiac abnormalities in patients with systemic lupus erythematosus (BeCarma)Efficacy of belimumab to improve subclinical cardiovascular abnormalitiesusing imaging endpoints with cardiac magnetic resonance in patients withsystemic lupus erythematosus (BeCarma) - BeCarma Efficacy of belimumab to improve subclinical cardiovascular abnormalities using imaging endpoints with cardiac magnetic resonance in patients with systemic lupus erythematosus
MedDRA version: 20.0;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes);System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta®Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Phase 4Germany
2EUCTR2018-004645-16-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
3EUCTR2018-004645-16-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
4EUCTR2018-004645-16-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
5NCT03370263
(ClinicalTrials.gov)
January 15, 20186/12/2017BENLYSTA® Special Drug Use InvestigationBENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use InvestigationSystemic Lupus ErythematosusDrug: BenlystaGlaxoSmithKlineNULLRecruitingN/AN/AAll600Japan
6NCT01532310
(ClinicalTrials.gov)
July 16, 20122/2/2012Belimumab (BENLYSTA®) Pregnancy RegistryWEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry ProtocolSystemic Lupus ErythematosusDrug: belimumabGlaxoSmithKlinePPDRecruitingN/AN/AFemale500United States
7EUCTR2007-007648-85-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

222. Primary nephrotic syndrome


Clinical trials : 285 Drugs : 285 - (DrugBank : 108) / Drug target genes : 62 - Drug target pathways : 191
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000242-38-CZ
(EUCTR)
14/02/201313/11/2012A 2 year study to investigate belimumab in membranous nephropathyBEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
94United States;France;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;United Kingdom;Italy
2EUCTR2011-000242-38-DE
(EUCTR)
09/01/201325/09/2012A 2 year study to investigate belimumab in membranous nephropathyBEL114674: A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 16.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
94France;United States;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;Italy;United Kingdom
3EUCTR2011-000242-38-ES
(EUCTR)
20/12/201222/10/2012A 2 year study to investigate belimumab in membranous nephropathyA 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
94United States;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
4EUCTR2011-000242-38-GB
(EUCTR)
01/11/201203/10/2012 A 2 year study to investigate belimumab in membranous nephropathy BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 15.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
5EUCTR2012-000385-38-GB
(EUCTR)
18/05/201202/04/2012A study to investigate belimumab in IMGN BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy Idiopathic Membranous Glomerulonephropathy (IMGN)
MedDRA version: 16.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;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 and Development LtdNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom