Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT02537028
Eligibility Criteria:
Inclusion Criteria:
* Male or female of 18 to 65 years of age
* Diagnosis of systemic lupus erythematosus (SLE) (at least 4 of the 11 American College of Rheumatology \[ACR\] classification criteria for SLE) of at least 6 months duration at the Screening visit
* Positive test results for anti-nuclear antibody (ANA) (human epithelial cell-2 ANA greater than or equal to \[\>=\] 1:80) and/or anti-dsDNA antibody (\>= 30 international units per milliliter \[IU/mL\]) at the Screening visit
* At least 1 SLE disease manifestation (assessed by Systemic Lupus Erythematosus Disease Activity Index-2000 \[SLEDAI-2K\]) other than positive antidsDNA and no central nervous system (CNS) SLE (psychosis, organic brain syndrome, cranial nerve disorder, lupus headache, or new-onset cerebrovascular accident)
* History of vaccinations as follows or vaccination against these pathogens during Screening:
1. Vaccination against Streptococcus pneumoniae with pneumococcal polysaccharide vaccine 23 or pneumococcal 13-valent conjugate vaccine as per local guidelines, and
2. Vaccination against influenza virus (as per local seasonal recommendations). Subjects receiving 1 or more of these vaccinations during screening must have at least 2 weeks between the vaccination(s) and the date of randomization at Day 1.
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Active clinically significant CNS SLE
* Initiation or change in dose of anti-malarial treatment after the screening visit
* Within 2 weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 40 mg daily prednisone equivalent, use of any injectable corticosteroids, or change in dose of corticosteroids
* Within 2 weeks prior to Screening, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, or nonsteroidal anti-inflammatory drugs (NSAIDs).
* Within 2 months prior to Screening or during Screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine
* Within 2 months prior to Screening or during Screening, use of cyclosporine, tacrolimus, leflunomide, abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, or other disease-modifying, immunosuppressive, or immunomodulatory therapies not otherwise specified in protocol
* Within 6 months prior to Screening or during Screening: use of cyclophosphamide or chlorambucil
* Within 12 months prior to screening or during screening: use of rituximab, belimumab, or any other B cell-depleting or modulating therapies
* Within 1 month prior to Screening or during Screening, vaccination with live or live-attenuated virus vaccine.
* Active clinically significant viral, bacterial or fungal infection, or any serious episode of infection requiring hospitalization within the last 6 months - Estimated glomerular filtration rate by the Modification of Diet in Renal Disease equation of less than (\<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2), or recent decline in kidney function, or proteinuria \>= 3 gram per day (g/day) (spot urine protein/creatinine ratio \>= 3 mg/mg)
* Other protocol defined exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02537028
Study Brief:
Protocol Section:
NCT02537028