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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT06411249
What this study is testing
What is Belimumab (GSK1550188)?
Belimumab (GSK1550188) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as BEL (BENLYSTA).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 first-line SLE therapy.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented diagnosis of systemic lupus erythematosus (SLE) within 2 years of signing the informed consent according to the European League Against...
- Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer greater than or equal to (\>=) 1:80 and/or a...
- 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)
You likely can't join if
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been...
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary...
- 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...
- A serious infection requiring treatment with intravenous or Intramuscular (IV/IM) antibiotics and/or hospitalization if the last dose of antibiotics...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Flagstaff, Arizona, United States
- Mesa, Arizona, United States
- Tucson, Arizona, United States
- Covina, California, United States
- Fontana, California, United States
- Fullerton, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Mission Hills, California, United States
- San Diego, California, United States
- Temecula, California, United States
- Tujunga, California, United States
- Van Nuys, California, United States
- Whittier, California, United States
- Aventura, Florida, United States
- Clearwater, Florida, United States
- Miami, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
+ 85 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Flagstaff, Arizona, United States; Mesa, Arizona, United States; Tucson, Arizona, United States; Covina, California, United States; Fontana, California, United States and 99 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.