Belimumab

Generic Name
Belimumab
Brand Names
Benlysta
Drug Type
Biotech
Chemical Formula
-
CAS Number
356547-88-1
Unique Ingredient Identifier
73B0K5S26A
Background

Belimumab is a fully human recombinant IgG1λ monoclonal antibody that inhibits soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B), a B cell survival factor. BLyS levels are often elevated in immunodeficient and autoimmune disorders, such as systemic lupus erythematosus (SLE). By binding to BLyS and blocking its intera...

Indication

In the US, belimumab is indicated to treat active systemic lupus erythematosus (SLE) and active lupus nephritis in patients aged five years and older who are receiving standard therapy. In Europe, belimumab is also used to treat SLE and lupus nephritis but only in adults.
...

Associated Conditions
Active Systemic Lupus Erythematosus, Lupus Nephritis
Associated Therapies
-

BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-05-14
Last Posted Date
2020-03-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
142
Registration Number
NCT01597622
Locations
🇰🇷

GSK Investigational Site, Suwon, Kyonggi-do, Korea, Republic of

A Study of Belimumab in the Prevention of Kidney Transplant Rejection

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-02-22
Last Posted Date
2017-04-25
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
30
Registration Number
NCT01536379
Locations
🇬🇧

GSK Investigational Site, London, United Kingdom

Belimumab (BENLYSTA®) Pregnancy Registry

Completed
Conditions
Interventions
First Posted Date
2012-02-14
Last Posted Date
2023-01-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
77
Registration Number
NCT01532310
Locations
🇨🇭

GSK Investigational Site, Zürich, Switzerland

A Study to Investigate Belimumab for the Treatment of Chronic Immune Thrombocytopenia.

First Posted Date
2011-09-26
Last Posted Date
2014-07-28
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT01440361

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-05-02
Last Posted Date
2019-10-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
709
Registration Number
NCT01345253
Locations
🇰🇷

GSK Investigational Site, Suwon, Kyonggi-do, Korea, Republic of

Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-07-12
Last Posted Date
2012-07-03
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
20
Registration Number
NCT01160666
Locations
🇫🇷

Assistance Publique - Hôpitaux de Paris : BICETRE Hospital, Le Kremlin Bicêtre, France

A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia

First Posted Date
2010-06-11
Last Posted Date
2012-02-10
Lead Sponsor
Cancer Trials Australia
Target Recruit Count
15
Registration Number
NCT01142011
Locations
🇦🇺

The Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

🇦🇺

Alfred Health, Melbourne, Victoria, Australia

Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2009-12-03
Last Posted Date
2017-06-12
Lead Sponsor
University of Pennsylvania
Target Recruit Count
8
Registration Number
NCT01025193
Locations
🇺🇸

University of Pennsyvlania Kidney Transplant Program, Philadelphia, Pennsylvania, United States

Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

First Posted Date
2009-07-02
Last Posted Date
2012-10-31
Lead Sponsor
Human Genome Sciences Inc., a GSK Company
Registration Number
NCT00931086
Locations
🇺🇸

Rheumatology Associates of Central Florida, Orlando, Florida, United States

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-07-10
Last Posted Date
2019-12-05
Lead Sponsor
Human Genome Sciences Inc., a GSK Company
Target Recruit Count
738
Registration Number
NCT00712933
Locations
🇬🇧

GSK Investigational Site, Newcastle Upon Tyne, United Kingdom

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