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.
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Associated Conditions: Active Systemic Lupus Erythematosus, Lupus Nephritis

Associated Therapies: -

Clinical Trials

The BeLimumab Antiphospholipid Syndrome Trial (BLAST)

Phase 2

Recruiting

Conditions: Antiphospholipid Syndrome

Interventions: Drug: Belimumab

First Posted Date: 2021-08-25

Last Posted Date: 2023-01-13

Lead Sponsor: University of Turin, Italy

Target Recruit Count: 15

Registration Number: NCT05020782

Locations: 🇮🇹
San Giovanni Bosco Hospital, Turin, Piedmont, Italy

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Phase 4

Recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Belimumab
Drug: Standard therapy

First Posted Date: 2021-06-01

Last Posted Date: 2022-12-07

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 65

Registration Number: NCT04908865

Locations: 🇨🇳
GSK Investigational Site, Xi'an, China

A Model About the Response of Belimumab in SLE

Phase 4

Not yet recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Belimumab

First Posted Date: 2021-05-19

Last Posted Date: 2023-09-21

Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Target Recruit Count: 72

Registration Number: NCT04893161

Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis

Phase 2

Terminated

Conditions: Multiple Sclerosis

Interventions: Drug: Continued Ocrelizumab
Drug: Belimumab
Drug: Short-course Ocrelizumab

First Posted Date: 2021-02-23

Last Posted Date: 2023-03-07

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 4

Registration Number: NCT04767698

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)

Phase 2

Recruiting

Conditions: Cryoglobulinemia
Vasculitis

Interventions: Drug: Placebo
Drug: Belimumab

First Posted Date: 2020-11-16

Last Posted Date: 2024-06-26

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 48

Registration Number: NCT04629144

Locations: 🇫🇷
CH Blois, Blois, France
🇫🇷
CHU (Haut-Lévêque), Bordeaux, France
🇫🇷
Hopital Bicetre, Le Kremlin-Bicêtre, France

and more 17 locations

Transcriptional and Immune Parameters of Response to Belimumab

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Belimumab

First Posted Date: 2020-09-30

Last Posted Date: 2024-06-11

Lead Sponsor: Biomedical Research Foundation, Academy of Athens

Target Recruit Count: 85

Registration Number: NCT04570306

Locations: 🇬🇷
BRFAA, Athens, Greece

Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Phase 1

Recruiting

Conditions: Idiopathic CD4 Lymphopenia

Interventions: Biological: Belimumab

First Posted Date: 2019-09-20

Last Posted Date: 2024-12-16

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 20

Registration Number: NCT04097561

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

Phase 2

Conditions: ANCA Associated Vasculitis
Granulomatosis With Polyangiitis

Interventions: Drug: Rituximab
Drug: Belimumab
Drug: Prednisolone

First Posted Date: 2019-05-30

Last Posted Date: 2022-03-08

Lead Sponsor: Rachel Jones

Target Recruit Count: 31

Registration Number: NCT03967925

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, United Kingdom
🇬🇧
Glasgow Royal Infirmary, Glasgow, United Kingdom
🇬🇧
Imperial College London, London, United Kingdom

and more 3 locations

Belimumab With Rituximab for Primary Membranous Nephropathy

Phase 2

Recruiting

Conditions: Membranous Nephropathy
Nephrotic Syndrome

Interventions: Drug: Belimumab
Drug: Placebo for Belimumab
Drug: Rituximab

First Posted Date: 2019-05-14

Last Posted Date: 2024-11-06

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 58

Registration Number: NCT03949855

Locations: 🇨🇦
Centre de recherche de l'Hôpital Maisonneuve-Rosemont Nephrology Department, Montréal, Quebec, Canada
🇺🇸
University of Alabama at Birmingham School of Medicine: Division of Nephrology, Birmingham, Alabama, United States
🇺🇸
University of Arkansas, Little Rock, Arkansas, United States

and more 19 locations

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Phase 2

Recruiting

Conditions: Systemic Sclerosis

Interventions: Other: Placebo Subcutaneous Injection
Drug: Belimumab
Other: Placebo Infusion
Drug: Rituximab
Drug: MMF

First Posted Date: 2019-02-18

Last Posted Date: 2024-03-01

Lead Sponsor: Hospital for Special Surgery, New York

Target Recruit Count: 30

Registration Number: NCT03844061

Locations: 🇺🇸
Hospital for Special Surgery, New York, New York, United States

Drug Development Updates

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