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Clinical trials for Belimumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    42 result(s) found for: Belimumab. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-004366-10 Sponsor Protocol Number: 0642 Start Date*: 2019-05-24
    Sponsor Name:University of Leicester
    Full Title: A Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN)
    Medical condition: Immunoglobulin A (IgA) nephropathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2025-000106-42 Sponsor Protocol Number: 213560 Start Date*: 2025-04-22
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Protocol Title: A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients with Active Systemic Lupus Eryth...
    Medical condition: Active Systemic Lupus Erythematosus (SLE)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-005672-42 Sponsor Protocol Number: HGS1006-C1112 Start Date*: 2013-06-11
    Sponsor Name:Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
    Full Title: A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus...
    Medical condition: Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004859 10025134 Lupus erythematosus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-003642-15 Sponsor Protocol Number: Belimumab bei ITP Start Date*: 2008-06-05
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: A Randomized, Double-blind Superiority Trial to Evaluate the Safety, Tolerability, and Efficacy of Belimumab in Refractory ITP Subjects
    Medical condition: Autoimmune thrombocytopenia (ITP) is a common disorder in which platelets are destroyed by autoantibodies. BAFF has been shown to be elevated in the serum of ITP patients. Blockage of BAFF has be...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004570-28 Sponsor Protocol Number: HGS1006-C1121 Start Date*: 2012-09-13
    Sponsor Name:Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Acti...
    Medical condition: Lupus Nephritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) GB (Completed) BE (Completed) ES (Completed) CZ (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-000241-21 Sponsor Protocol Number: BEL114870 Start Date*: 2011-06-23
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A clinical and mechanistic proof of efficacy study with belimumab in chronic immune thrombocytopenia (ITP) patients
    Medical condition: Chronic Immune Thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10051057 Idiopathic thrombocytopenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-006215-56 Sponsor Protocol Number: BEL114424 Start Date*: 2012-07-31
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: BEL114424: A Phase 2 Pilot, Multicentered, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Potential for Efficacy and the Safety of Belimumab plus Standard of Care versus Placebo...
    Medical condition: Allograft Rejection in Adult Subjects After Renal Transplantation.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-005667-25 Sponsor Protocol Number: HGS1006-C1113 Start Date*: 2013-01-22
    Sponsor Name:GlaxoSmithKline, LLC
    Full Title: A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
    Medical condition: Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) CZ (Completed) EE (Completed) ES (Completed) IT (Completed) PT (Completed) BG (Completed) SK (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2012-000385-38 Sponsor Protocol Number: BEL116472 Start Date*: 2012-05-18
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy
    Medical condition: Idiopathic Membranous Glomerulonephropathy (IMGN)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10027170 Membranous nephropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-003814-18 Sponsor Protocol Number: HGS1006-C1115 Start Date*: 2012-05-03
    Sponsor Name:Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Sys...
    Medical condition: Systemic lupus erythematosis (SLE)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10042944 Systemic lupus erythematosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) CZ (Completed) SE (Completed) BE (Completed) PT (Completed) ES (Completed) DK (Completed) GB (Completed) BG (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-003839-11 Sponsor Protocol Number: 1352_0PBG_2017 Start Date*: 2018-03-05
    Sponsor Name:IRCCS Ospedale PedT..trico Bambino Gesù
    Full Title: Belimumab for the treatment of frequently relapsing nephrotic syndrome open label phase II trial. BELNEPH STUDY
    Medical condition: frequently relapsing nephrotic syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2025-000142-26 Sponsor Protocol Number: 217091 Start Date*: 2025-04-29
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Paediatric Participants with Systemic Lupus Er...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2006-005177-21 Sponsor Protocol Number: HGS1006-C1056 Start Date*: 2007-05-29
    Sponsor Name:Human Genome Sciences, Inc.
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Ant...
    Medical condition: Systemic Lupus Erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10042945 Systemic lupus erythematosus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) AT (Completed) CZ (Completed) ES (Completed) SK (Completed) SE (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004569-33 Sponsor Protocol Number: HGS1006-C1100 Start Date*: 2012-12-20
    Sponsor Name:Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
    Full Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission ...
    Medical condition: Wegener’s granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10047065 - Vascular disorders 10047888 Wegener's granulomatosis LLT
    16.1 10047065 - Vascular disorders 10063344 Microscopic polyangiitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) BE (Completed) ES (Completed) IE (Completed) SE (Completed) HU (Completed) IT (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-004645-24 Sponsor Protocol Number: 206852 Start Date*: 2018-11-09
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    Full Title: A randomized, double blind, controlled mechanistic study of rituximab and belimumab combination therapy in PR3 ANCA-associated vasculitis
    Medical condition: ANCA-associated vasculitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10050894 Anti-neutrophil cytoplasmic antibody positive vasculitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-000368-88 Sponsor Protocol Number: BEL114055 Start Date*: 2012-06-13
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Sta...
    Medical condition: Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) PL (Completed) NL (Ongoing) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003050-32 Sponsor Protocol Number: 205646 Start Date*: 2018-01-09
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subject...
    Medical condition: Systemic Lupus Erythematosus (SLE) or Lupus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004645-16 Sponsor Protocol Number: 200908 Start Date*: 2019-12-27
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therap...
    Medical condition: Lupus - SLE
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Ongoing) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-000242-38 Sponsor Protocol Number: BEL114674 Start Date*: 2013-01-09
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy
    Medical condition: Idiopathic Membranous Nephropathy (IMN)
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004857 10027170 Membranous nephropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) ES (Prematurely Ended) CZ (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002127-26 Sponsor Protocol Number: BAFFI_14 Start Date*: 2015-10-13
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: Randomized, single-blind, controlled study of the anti-BAFF antibody belimumab or methylprednisolone treatment in hyperthyroid Graves' disease (GD) and active orbitopathy (GO)
    Medical condition: GRAVES' ORBITOPATHY
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057889 Graves' ophthalmopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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