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ClinicalTrials.gov public records Last synced Oct 28, 2026, 3:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Showing 1–24 of 50 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Benlysta Clear all
Recruiting Phase 1 Interventional

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

NCT04097561
View directory record Official record
Conditions
Idiopathic CD4 Lymphopenia
Interventions
Belimumab
Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 16, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

NCT03312907
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
292 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
28
States / cities
Birmingham, Alabama • La Mesa, California • San Leandro, California + 22 more
Source: ClinicalTrials.gov public record
Updated Feb 18, 2025 · Synced Oct 28, 2026, 3:57 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)

NCT04179032
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab
Combination Product
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
5 Years to 17 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Recruiting Phase 4 Interventional

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

NCT07225387
View directory record Official record
Conditions
Lupus Nephritis
Interventions
Voclosporin
Drug
Lead sponsor
NephroNet, Inc.
Other
Eligibility
18 Years to 80 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
7
States / cities
Glendale, Arizona • Atlanta, Georgia • Lawrenceville, Georgia + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 6, 2025 · Synced Oct 28, 2026, 3:57 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

NCT06576271
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
GSK4527363, Placebo matching GSK4527363, Belimumab
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 65 Years
Enrollment
142 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2028
U.S. locations
6
States / cities
Scottsdale, Arizona • Aurora, Colorado • Las Vegas, Nevada + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Completed No phase listed Observational Results available

Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

NCT01729455
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Benlysta, Standard of Care (SoC) Therapy
Biological · Other
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
3,138 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2025
U.S. locations
102
States / cities
Birmingham, Alabama • Glendale, Arizona • Goodyear, Arizona + 85 more
Source: ClinicalTrials.gov public record
Updated Mar 20, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
No Longer Available No phase listed Expanded access

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

NCT00931086
View directory record Official record
Conditions
Rheumatoid Arthritis
Interventions
belimumab
Drug
Lead sponsor
Human Genome Sciences Inc., a GSK Company
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Oct 31, 2012 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 2 Interventional Results available

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

NCT01649765
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab 10 mg/kg, Placebo
Drug · Other
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
5 Years to 17 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2025
U.S. locations
7
States / cities
Phoenix, Arizona • Washington D.C., District of Columbia • Augusta, Georgia + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 20, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 3 Interventional Results available

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

NCT02119156
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
3
States / cities
Los Angeles, California • Manhasset, New York • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jan 31, 2020 · Synced Oct 28, 2026, 3:57 AM EDT
No Longer Available No phase listed Expanded access

Compassionate Use for Subcutaneous (SC) Belimumab

NCT03125486
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
SC belimumab 200 mg
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Feb 28, 2018 · Synced Oct 28, 2026, 3:57 AM EDT
Withdrawn Phase 2 Interventional

Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

NCT01762852
View directory record Official record
Conditions
Glomerulonephritis, Membranous
Interventions
Belimumab 10 mg, Placebo
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 75 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
2
States / cities
St Louis, Missouri • Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 22, 2017 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

NCT00071487
View directory record Official record
Conditions
Lupus Erythematosus, Systemic
Interventions
Placebo, Belimumab 1 mg/kg, Belimumab 4 mg/kg, Belimumab 10 mg/kg
Drug
Lead sponsor
Human Genome Sciences Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
449 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
60
States / cities
Birmingham, Alabama • Paradise Valley, Arizona • Tucson, Arizona + 52 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2013 · Synced Oct 28, 2026, 3:57 AM EDT
Active, not recruiting Phase 4 Interventional

A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

NCT06411249
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab (GSK1550188)
Biological
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
302 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
40
States / cities
Anniston, Alabama • Flagstaff, Arizona • Mesa, Arizona + 36 more
Source: ClinicalTrials.gov public record
Updated Oct 27, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Recruiting Phase 2 Interventional

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

NCT07138898
View directory record Official record
Conditions
Rheumatic Disease
Interventions
Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide, Azathioprine, Mycophenolate, Cyclosporine, Tacrolimus, Etanercept, Adalimumab, Golimumab, Certolizumab, Infliximab, Rituximab, Belimumab, Tocilizumab, Anakinra, Canakinumab, Abatacept, Secukinumab, Ixekizumab, Bimekizumab, Ustekinumab, Guselkumab, Risankizumab, Tofacitinib, Upadacitinib
Drug · Biological
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 9, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Terminated Phase 2 Interventional Results available

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

NCT04767698
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
Belimumab, Short-course Ocrelizumab, Continued Ocrelizumab
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 7, 2023 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 4 Interventional Results available

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

NCT01597492
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab plus Early Vaccination, Belimumab plus Late Vaccination
Biological
Lead sponsor
Human Genome Sciences Inc., a GSK Company
Industry
Eligibility
18 Years and older
Enrollment
79 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
15
States / cities
Birmingham, Alabama • Paradise Valley, Arizona • Shreveport, Louisiana + 11 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2018 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 3 Interventional Results available

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

NCT00410384
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Placebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg
Drug
Lead sponsor
Human Genome Sciences Inc.
Industry
Eligibility
18 Years and older
Enrollment
819 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2010
U.S. locations
67
States / cities
Birmingham, Alabama • Paradise Valley, Arizona • Tucson, Arizona + 56 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2017 · Synced Oct 28, 2026, 3:57 AM EDT
Terminated Phase 2 Interventional Results available

Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

NCT00732940
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Belimumab 100 mg SC
Drug
Lead sponsor
Human Genome Sciences Inc.
Industry
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
10
States / cities
Birmingham, Alabama • Long Beach, California • Tampa, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2013 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Belimumab in Idiopathic Inflammatory Myositis

NCT02347891
View directory record Official record
Conditions
Myositis
Interventions
Belimumab, Placebo
Drug
Lead sponsor
Northwell Health
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
1
States / cities
Great Neck, New York
Source: ClinicalTrials.gov public record
Updated Feb 9, 2024 · Synced Oct 28, 2026, 3:57 AM EDT
Terminated Phase 2 Interventional Results available

CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients

NCT03591380
View directory record Official record
Conditions
Kidney Transplantation
Interventions
Belimumab
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 60 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jan 9, 2023 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 4 Interventional Results available

Belimumab Assessment of Safety in SLE

NCT01705977
View directory record Official record
Conditions
Systemic Lupus Erythematosus
Interventions
Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
Biological · Other
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
4,019 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2022
U.S. locations
49
States / cities
Anniston, Alabama • Birmingham, Alabama • Huntsville, Alabama + 41 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2024 · Synced Oct 28, 2026, 3:57 AM EDT
Terminated Phase 2 Interventional Results available

A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

NCT00583557
View directory record Official record
Conditions
Rheumatoid Arthritis
Interventions
belimumab
Drug
Lead sponsor
Human Genome Sciences Inc.
Industry
Eligibility
18 Years and older
Enrollment
155 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
44
States / cities
Birmingham, Alabama • Paradise Valley, Arizona • Scottsdale, Arizona + 38 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2013 · Synced Oct 28, 2026, 3:57 AM EDT
Recruiting Phase 4 Interventional

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

NCT07611214
View directory record Official record
Conditions
Lupus Nephritis
Interventions
LUPKYNIS, belimumab, obinutuzumab or anifrolumab, mycophenolic acid analog (MPAA), corticosteroid
Drug · Biological
Lead sponsor
Aurinia Pharmaceuticals Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
27
States / cities
La Mesa, California • Los Alamitos, California • Arvada, Colorado + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2026 · Synced Oct 28, 2026, 3:57 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study of Belimumab Administered Subcutaneously to Healthy Subjects

NCT01583530
View directory record Official record
Conditions
Healthy
Interventions
Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg, Single Dose Group: Belimumab SC 1 x 200 mg, Multiple Dose Group: Belimumab SC 2 x 120 mg weekly, Multiple Dose Group: Belimumab SC 1 x 200 mg weekly
Biological
Lead sponsor
Human Genome Sciences Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
118 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
4
States / cities
Daytona Beach, Florida • Evansville, Indiana • Dallas, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2013 · Synced Oct 28, 2026, 3:57 AM EDT