New study tests belimumab to tame early lupus

NCT ID NCT06411249

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study is testing the drug belimumab (Benlysta) in 350 adults who were diagnosed with systemic lupus erythematosus (SLE) within the last two years and still have active disease despite standard treatment. The goal is to see if adding belimumab helps more people reach a state of low disease activity and reduce their need for steroids over three years. Participants will receive weekly injections of belimumab at home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: belimumab (Benlysta)
What this could lead to: If successful, this study could show that early use of belimumab helps people with lupus achieve a low disease activity state, potentially reducing flares and reliance on steroids.
What could go wrong: This is an open-label, single-arm study with no placebo group, so results may be less definitive. Belimumab can increase the risk of infections and allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

303 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented diagnosis of systemic lupus erythematosus (SLE) within 2 years of signing the informed consent according to the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria 2019 * Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer greater than or equal to (\>=) 1:80 and/or a positive anti-Double stranded deoxyribonucleic acid (dsDNA) serum antibody test from 2 independent time points * Active SLE defined as: * Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score greater than (\>) 4, OR * Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score 1 to 4 and prednisone or equivalent dose \>=10 milligram per day (mg/day) * The Systematic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) = 0 at Screening * Male and/or female; a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a Woman of childbearing potential (WOCBP) OR * Is a WOCBP and using a contraceptive method that is highly effective * Capable of giving signed informed consent Exclusion Criteria: * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal (GI), hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put the participant at undue risk. * Participants with history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant. * Have an acute or chronic infection including requiring management as follows: * Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. * A serious infection requiring treatment with intravenous or Intramuscular (IV/IM) antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed. * Confirmed active or untreated latent tuberculosis (TB): * Diagnosis of active TB confirmed by: 1) evidence of active TB disease from chest imaging (posterior anterior and lateral x-rays or chest computed tomography \[CT\]), 2) medical history and physical examination, and 3) either positive microscopy smear/culture for mycobacteria or positive TB polymerase chain reaction (PCR), i.e., Xpert. A tuberculin skin test (TST) or an interferon gamma release assay (IGRA) will be done for all participants. A positive TST or a positive (not indeterminate) IGRA TB test such as QuantiFERON-TB Gold Plus test is indicative but not required for diagnosis of active TB. A positive TST is defined as a skin induration \>=5 millimeter (mm) at 48 to 72 hours (regardless of Bacillus Calmette-Guerin or other vaccination history). * Untreated latent tuberculosis infection (LTBI) confirmed by: 1) no evidence of active TB based on chest imaging, medical history and physical examination and laboratory evaluation of sputum; and 2) a positive TST, defined as a skin induration \>5 mm at 48 to 72 hours, regardless of Bacillus Calmette-Guerin or other vaccination history); or a positive (not indeterminate) IGRA TB test such as QuantiFERON-TB Gold Plus test. Those with IGRA positive tests or positive TST who can document ongoing LTBI treatment for at least 4 weeks may be enrolled. Those with IGRA positive tests with documentation of the following may also be enrolled: * Successful completion of treatment for active TB. * Completion of treatment for LTBI (with treatment as per local practice, for example: 3 months of isoniazid and rifampin or 4 months of rifampin or 3 months weekly isoniazid and rifapentine, or 9 months of isoniazid). * Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms. * Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, Cerebrovascular accident (CVA), cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Screening. * Active Lupus Nephritis defined as active urinary sediment and/or proteinuria \>500 milligrams (mg) per 24 hours, or equivalent using spot urine protein to creatinine ratio, requiring induction therapy not permitted by protocol. * Participants with patient health questionnaire (PHQ)-9 score \>=10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk. NOTE: For participants with a PHQ-9 score \>=10, at the Screening visit or at the day 1 visit before the first administration of the study drug, it is required that they be referred for an assessment by a mental healthcare professional (e.g., locally licensed psychiatrist, psychologist, or master's level therapist) before the investigator makes a final decision regarding suitability for enrollment. * Known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with diagnostic or therapeutic monoclonal antibodies * Live or live-attenuated vaccine(s) within 35 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study * Chronic oral steroid use for a non-SLE disorder at the Screening study visit (e.g., for asthma). Inhaled steroid use will be allowed. * Treatment at or prior to Screening study visit: * Treatment at Screening study visit with any of the following: * Azathioprine (AZA) \>200 mg/day * Methotrexate (MTX) (any formulation) \>25 mg/week * Mycophenolate mofetil (MMF) (oral \[PO\])/MMF hydrochloride (IV) \>2 grams (g)/day * Mycophenolate acid/sodium (PO) \>1.44 g/day * Oral cyclophosphamide \>2.5 mg/kilograms (kg)/day * Tacrolimus \>0.2 mg/kg/day * Cyclosporine (PO) \>2.5 mg/kg/day * Treatment within specified timeframe prior to Screening: * Intra-articular, IM, or IV corticosteroids within 6 weeks of Day 1 * Daily use of \>1 Nonsteroidal anti-inflammatory (NSAID) within 2 weeks prior to Day 1 * Treatment at any time prior to Screening with any of the following: * Second line use of conventional immunosuppressants (ISs) or anti-malarials (AMs) * Commercially available Belimumab (BEL) * Anifrolumab * Rituximab or other B cell depleting therapies * Anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab, etanercept, infliximab) * Other treatments with effects on the immune system (e.g., abatacept, interleukin-1 receptor antagonist \[anakinra\], Janus kinase (JAK) inhibitors) * IV cyclophosphamide * IV immunoglobulin * Plasmapheresis Any addition of a new IS or AM, or IS or AM switch, performed more than 3 months after initiating first line therapy in response to inadequate disease control is considered second-line therapy and is therefore exclusionary. Therapy changes made due to intolerance or toxicity are not considered second-line, provided that the intolerance/toxicity is clearly documented. Any therapy changes after initiating first line therapy considered to be due to intolerance/toxicity must be reviewed and confirmed by the EAC prior to determining eligibility. * History of primary immunodeficiency, or hypogammaglobulinemia (Immunoglobulin G \[IgG\] \<400 mg/deciliter \[dL\]) or Immunoglobulin A (IgA) deficiency (IgA \<10 mg/dL) at Screening * Have a Grade 3 or greater neutropenia, defined as absolute neutrophil count \<1000/cubic millimeter (mm3) (\<1.0 x10\^9/liter \[L\]) based on the Common terminology criteria for adverse events (CTCAE) version (v) 5.0 * Alanine aminotransferase \>2 x upper limit of normal (ULN) * Total bilirubin \>1.5 x ULN; For participants with Gilbert's syndrome can be included with total bilirubin \>1.5xULN if direct bilirubin is ≤1.5xULN. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome), asymptomatic gallstones, and chronic stable hepatitis B (in whom Hepatitis D \[HDV\] has been excluded) or C are acceptable if participant otherwise meets entry criteria. * Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data. * Positive Human immunodeficiency virus (HIV) antibody test * Serologic evidence of Hepatitis B (HB) infection based on the results of testing for hepatitis B surface antigen (HBsAg), anti-hepatitis B core (HBc) and anti-HBs will be excluded as follows: * Participants positive for HBsAg. * Participants negative for HBsAg but positive for Anti-HBc and detectable hepatitis B virus (HBV) DNA, regardless of Anti-HBs antibody status. * Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention. NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C Ribonucleic acid (RNA) test is obtained. * Positive Hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention. NOTE: Test is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing. * Sensitivity to the clinical study intervention, or components thereof, or monoclonal antibodies or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the clinical study * Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1 * Current enrolment or past participation in any other clinical study involving an investigational study intervention (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug (whichever is longer) before enrolment * Unable to administer clinical study intervention by subcutaneous (SC) auto-injector at home and has no other reliable resource to administer the study intervention at home.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune disease systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

GSK Investigational Site

Anniston, Alabama, 36207, United States
GSK Investigational Site

Flagstaff, Arizona, 86001, United States
GSK Investigational Site

Mesa, Arizona, 85210, United States
GSK Investigational Site

Tucson, Arizona, 85748, United States
GSK Investigational Site

Covina, California, 91722, United States
GSK Investigational Site

Fontana, California, 92335, United States
GSK Investigational Site

Fullerton, California, 92835, United States
GSK Investigational Site

Long Beach, California, 90720, United States
GSK Investigational Site

Los Angeles, California, 90211, United States
GSK Investigational Site

Mission Hills, California, 91345, United States
GSK Investigational Site

San Diego, California, 92128, United States
GSK Investigational Site

Temecula, California, 92592, United States
GSK Investigational Site

Tujunga, California, 91042, United States
GSK Investigational Site

Van Nuys, California, 92307-2333, United States
GSK Investigational Site

Van Nuys, California, 92586, United States
GSK Investigational Site

Whittier, California, 90602, United States
GSK Investigational Site

Aventura, Florida, 33180, United States
GSK Investigational Site

Clearwater, Florida, 33765, United States
GSK Investigational Site

Tamarac, Florida, 33321, United States
GSK Investigational Site

Tampa, Florida, 33606, United States
GSK Investigational Site

Atlanta, Georgia, 30152, United States
GSK Investigational Site

Morton Grove, Illinois, 60521, United States
GSK Investigational Site

Rockford, Illinois, 60123, United States
GSK Investigational Site

Baton Rouge, Louisiana, 70836, United States
GSK Investigational Site

New Orleans, Louisiana, 70112, United States
GSK Investigational Site

Detroit, Michigan, 48202, United States
GSK Investigational Site

Lansing, Michigan, 48910, United States
GSK Investigational Site

Brooklyn, New York, 11201, United States
GSK Investigational Site

Charlotte, North Carolina, 28202, United States
GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site

Austin, Texas, 78745, United States
GSK Investigational Site

Baytown, Texas, 77521, United States
GSK Investigational Site

Colleyville, Texas, 76034, United States
GSK Investigational Site

Fort Worth, Texas, 76109, United States
GSK Investigational Site

Houston, Texas, 77089, United States
GSK Investigational Site

Katy, Texas, 77494, United States
GSK Investigational Site

Plano, Texas, 75024, United States
GSK Investigational Site

Danville, Virginia, 24541, United States
GSK Investigational Site

Glendale, Wisconsin, 53217, United States
GSK Investigational Site

Berazategui, 1884, Argentina
GSK Investigational Site

Buenos Aires, C1121ABE, Argentina
GSK Investigational Site

Buenos Aires, C1406AGA, Argentina
GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1425, Argentina
GSK Investigational Site

La Plata, B1900AX, Argentina
GSK Investigational Site

Mar del Plata, 7600, Argentina
GSK Investigational Site

Quilmes, B1878GEG, Argentina
GSK Investigational Site

San Miguel de Tucumán, CP 4000, Argentina
GSK Investigational Site

Santa Fe, S2000DSV, Argentina
GSK Investigational Site

Belo Horizonte, 30150-221., Brazil
GSK Investigational Site

Cuiabá, 78020-840, Brazil
GSK Investigational Site

Juiz de Fora, 36010-570, Brazil
GSK Investigational Site

Passo Fundo, 99010-080, Brazil
GSK Investigational Site

Porto Alegre, 90035-001, Brazil
GSK Investigational Site

Porto Alegre, 90430-001, Brazil
GSK Investigational Site

Porto Alegre, 90610-000, Brazil
GSK Investigational Site

Salvador, 41820-020, Brazil
GSK Investigational Site

São José do Rio Preto, 15090-000, Brazil
GSK Investigational Site

São Paulo, 01323-001, Brazil
GSK Investigational Site

São Paulo, 05403-000, Brazil
GSK Investigational Site

Angers, 49933, France
GSK Investigational Site

Lille, 59800, France
GSK Investigational Site

Pessac, 33604, France
GSK Investigational Site

Rennes, 35200, France
GSK Investigational Site

Saint-Priest-en-Jarez, 42270, France
GSK Investigational Site

Toulouse, 31400, France
GSK Investigational Site

Herne, 44649, Germany
GSK Investigational Site

Lübeck, 23538, Germany
GSK Investigational Site

Mainz, 55131, Germany
GSK Investigational Site

Meerbusch, 40668, Germany
GSK Investigational Site

Athens, 11 527, Greece
GSK Investigational Site

Athens, 12462, Greece
GSK Investigational Site

Athens, 16673, Greece
GSK Investigational Site

Heraklion, 71500, Greece
GSK Investigational Site

Thessaloniki, 54642, Greece
GSK Investigational Site

Brescia, 25123, Italy
GSK Investigational Site

Ferrara, 44124, Italy
GSK Investigational Site

Milan, 20132, Italy
GSK Investigational Site

Pisa, 56100, Italy
GSK Investigational Site

Reggio Emilia, 42123, Italy
GSK Investigational Site

Rome, 00168, Italy
GSK Investigational Site

Rozzano, 20089, Italy
GSK Investigational Site

Fukuoka, 807-8556, Japan
GSK Investigational Site

Kanagawa, 252-0375, Japan
GSK Investigational Site

Miyagi, 980-8574, Japan
GSK Investigational Site

Osaka, 590-0197, Japan
GSK Investigational Site

Tokyo, 104-8560, Japan
GSK Investigational Site

Cuauhtémoc, Mexico City, 06090, Mexico
GSK Investigational Site

DF, 14000, Mexico
GSK Investigational Site

Guadalajara Jalisco, 44950, Mexico
GSK Investigational Site

León, 37000, Mexico
GSK Investigational Site

Mexico City, 06700, Mexico
GSK Investigational Site

Mexico City, 06726, Mexico
GSK Investigational Site

Mérida, 97000, Mexico
GSK Investigational Site

Monterrey Nuevo LeOn, 64000, Mexico
GSK Investigational Site

San Luis Potosí City, 78200, Mexico
GSK Investigational Site

Torreón, 27000, Mexico
GSK Investigational Site

Almada, 2805-267, Portugal
GSK Investigational Site

Lisbon, 1069-166, Portugal
GSK Investigational Site

Porto, 4050-342, Portugal
GSK Investigational Site

Barcelona, 08003, Spain
GSK Investigational Site

Castellon, 12004, Spain
GSK Investigational Site

Córdoba, 14004, Spain
GSK Investigational Site

Murcia, 30120, Spain
GSK Investigational Site

Valladolid, 47012, Spain
GSK Investigational Site

VigoPontevedra, 36213, Spain
GSK Investigational Site

Villajoyosa, 3570, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.