Lupus Erythematosus, Systemic
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.
Interventions
DRUGJNJ-56022473
Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
DRUGPlacebo
Subjects will receive matching placebo.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening * Subjects eligible for enrollment in this study must qualify as follows: a) must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) within 3 months prior to first study agent administration * Have a positive gene signature score during screening, prior to first administration of study agent * Subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication: 1. oral corticosteroids equivalent to an average dose up to or equal to (\<=) 10 milligram (mg) of prednisone/day 2. use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks 3. maximum of 1 non-corticosteroid immunosuppressive drug
Exclusion criteria
* Subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (SLE) * Subject has unstable lupus nephritis and/ or has active Central nervous system (CNS) lupus or history of severe CNS lupus, including but not limited to seizures, psychosis, transverse myelitis, CNS vasculitis and optic neuritis * Major surgery prior to, and, if planned, during and shortly after the study is not eligible * Subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit * Any other inflammatory diseases that might confound the evaluations of efficacy are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16 | Up to 16 weeks |
| Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration | Up to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of JNJ-56022473 | Up to 16 weeks | — |
| Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies | Up to 16 weeks | — |
| Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR) | Up to 38 weeks | Whole blood samples collected from subjects enrolled in this study will be examined by qPCR to assess the ability of JNJ-56022473 to initiate the expected effect on target cells. |
| Counts of Target Cells | Up to 38 weeks | Counts of target cells will be measured by flow cytometry from whole blood. |
Countries
Germany
Outcome results
None listed