Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lakefront Biotherapeutics NV
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
SLE diagnosis defined by American College of Rheumatology (ACR) 1997 criteria ≥4
Active arthritis in \>=4 active joints (according to 28 joint count) and/or cutaneous lupus erythematosus disease area and severity index (CLASI) score \>=6.
Anti-dsDNA antibodies \>15 IU/mL.
Stable standard-of-care (SoC) therapy (defined as no change in prescription for at least 2 weeks prior to first IP dosing) consisting of the following permitted SoC medications:
* Corticosteroids \<=20 mg/day (prednisone or equivalent) for at least 2 weeks prior to first IP dosing; AND/OR
* Non-steroidal anti-inflammatory drug (NSAIDs); AND/OR
* One single antimalarial at a stable dose (hydroxychloroquine \<=5 mg/ kg/day, quinacrine 100 mg/day, or chloroquine 2.3 mg/kg/day) for at least 8 weeks prior to first IP dosing; AND/OR
* One single immunosuppressant at a stable dose (azathioprine (AZA) \<=2 mg/kg/day, methotrexate (MTX) \<=20 mg/week, or mycophenolate mofetil (MMF) \<=2 g/day) for at least 8 weeks prior to first IP dosing.
Severe organ manifestation or life-threatening lupus disease (active severe central nervous system lupus, severe pleuro-pericarditis, severe vasculitis).
Severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection \>0
Unstable condition not related to SLE
Systemic inflammatory condition other than SLE such as, but not limited to rheumatoid arthritis (RA), spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis
Sjögren's syndrome and/or antiphospholipid antibody syndrome who do not require treatment with any prohibited medication are NOT excluded.
Active systemic infection
Poorly controlled chronic cardiac, pulmonary, or renal disease.
Known or suspected history of or a current immunosuppressive condition, or a history of invasive opportunistic infections
