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

Study Purpose

This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Documented clinical diagnosis of SLE within 2 years of signing the informed consent according to the American College of Rheumatology (ACR) SLE classification criteria 2019.

- Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer ≥1:80 and/or a positive anti- Double stranded deoxyribonucleic acid (dsDNA) serum antibody test from 2 independent time points as follows: - 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) ≤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 Women 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.

- 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.

- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior, anterior, and lateral), and TB testing: either a positive tuberculin skin test (TST); defined as a skin induration ≥5millimeter (mm) at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) interferon gamma release assay TB test.

- 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.

- Lupus kidney disease defined by proteinuria >6 gram (g)/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine >2.5 milligram per decilitre (mg/dL) or have active LN requiring induction therapy within 35 days of Screening.

- Have evidence of serious suicide risk, defined as Patient Health Questionnaire (PHQ)-9 score ≥10, 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 opinion, pose a significant suicide risk.

- 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) (PO)/MMF hydrochloride (IV) >2 g/day.

- Mycophenolate acid/sodium (PO) >1.44 g/day.

- Oral cyclophosphamide >2.5 mg/kg/day.

- Tacrolimus >0.2 mg/kg/day.

- Cyclosporine (PO) >2.5 mg/kg/day.

• Treatment at any time prior to Screening with any of the following:

- Second line use of conventional ISs or AMs.

- Commercially available Belimumab (BEL) - Anifrolumab.

- Rituximab or other B cell depleting therapies.

- Anti-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.

- 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.

- History of primary immunodeficiency, or hypogammaglobulinemia (Immunoglobulin G [IgG] <400 mg/dL) or Immunoglobulin A (IgA) deficiency (IgA <10 mg/dL) - Have a Grade 3 or greater neutropenia, defined as absolute neutrophil count <1000/cubic millimetre (mm3) (<1.0 x109/L) based on the Common terminology criteria for adverse events (CTCAE) v5.0 Alanine aminotransferase >2 x upper limit of normal (ULN) - Total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]) - 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.

- Presence of hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.

- 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 and has no other reliable resource to administer the study intervention.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06411249
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	GlaxoSmithKline
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	GSK Clinical Trials
Principal Investigator Affiliation	GlaxoSmithKline
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, France, Germany, Greece, Italy, Japan, Mexico, Portugal, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus

Arms & Interventions

Arms

Experimental: Belimumab (GSK1550188)

Participants will receive GSK1550188.

Interventions

Drug: - Belimumab (GSK1550188)

GSK1550188 will be administered subcutaneously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

GSK Investigational Site, Anniston, Alabama

Status

Not yet recruiting

Address

GSK Investigational Site

Anniston, Alabama, 36207

Site Contact

US GSK Clinical Trials Call Center

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