Last updated: 10/14/2025 14:20:10
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants with Early Systemic Lupus Erythematosus (SLE)BE-EARLY
GSK study ID
219240
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants with Early Systemic Lupus Erythematosus
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
Timeframe: At Week 52
Secondary outcomes:
Part A: Percentage of Participants Achieving SLE Responder Index 4 (SRI4) at Week 52
Timeframe: At Week 52
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) for ≥ 25 percent (%) of time from Day 1 to Week 52
Timeframe: Day 1 and up to Week 52
Part A: Percentage of Participants Achieving Average Oral Prednisone Equivalent Dose ≤ 5 mg/day at Week 52
Timeframe: At Week 52
Part A: Estimate of probability of having a Severe Flare defined as modified SELENA-SLEDAI Flare Index (SFI) at Week 52
Timeframe: At Week 52
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score at Week 52
Timeframe: At Week 52
Part A: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) up to Week 52
Timeframe: Up to Week 52
Part B: Percentage of Participants Achieving Definition of Remission in SLE (DORIS) Remission at Week 104
Timeframe: At Week 104
Part B: Percentage of Participants Maintaining Systematic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) of 0 up to Week 156
Timeframe: Up to Week 156
Part B: Number of Participants With AEs, SAEs, and AESIs up to Week 104 and Week 156
Timeframe: Up to Week 104 and Week 156
Interventions:
Enrollment:
350
Primary completion date:
2027-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
June 2024 to May 2029
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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) less than or equal 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
- 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 x109/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 (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]). Participants with Gilbert’s syndrome can be included with total bilirubin >1.5xULN as long as 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.
Trial location(s)
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Study documents
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Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
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