BENLYSTA® (belimumab) ( DrugBank: Belimumab )

3 diseases
告示番号疾患名（ページ内リンク）臨床試験数
11重症筋無力症2
66IgA腎症1
222一次性ネフローゼ症候群1

11. 重症筋無力症

臨床試験数 : 332 /  薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2011-002068-26-IT
(EUCTR)		28/12/201115/12/2011A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) - Evaluate the Use of Belimumab in Myasthenia Gravis (MG) Subjects with Generalized Myasthenia Gravis (MG)
MedDRA version: 14.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Trade Name: BENLYSTA® (belimumab)
INN or Proposed INN: BELIMUMAB		GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes		42United States;Canada;Germany;Italy
2EUCTR2011-002068-26-DE
(EUCTR)		24/11/201105/10/2011A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG). Myasthenia Gravis
MedDRA version: 17.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Trade Name: BENLYSTA® (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab		GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes		42United States;Canada;Germany;Italy

66. IgA腎症

臨床試験数 : 275 /  薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2017-004366-10-GB
(EUCTR)		24/05/201904/02/2019Efficacy and Safety of Belimumab in the Treatment of IgA NephropathyA Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy Immunoglobulin A (IgA) nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary 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
Other descriptive name: GSK1550188; Benlysta		University of LeicesterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		21 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

222. 一次性ネフローゼ症候群

臨床試験数 : 310 /  薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2012-000385-38-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