Systemic Lupus Erythematosus
Conditions
Brief summary
This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.
Interventions
GLPG3970 for oral administration
Placebo for oral administration
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * estimated glomerular filtration rate (eGFR) \>=60 mL/min (according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)) This list only contains the key inclusion criteria.
Exclusion criteria
* Lupus nephritis \>= Class III * 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 * Treatment with disallowed therapies This list only contains the key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers associated with disease anti-dsDNA | Between Day 1 and 104 | To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE |
| Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4) | Between Day 1 and 104 | To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE |
| Number, incidence, and severity of treatment-emergent adverse events (TEAEs) | From screening through study completion, an average of 5 months | To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed GLPG3970 plasma trough concentrations (Ctrough) | Between Day 1 and 87 | To characterize the PK of GLPG3970 in adult subjects with active SLE |
Countries
Bulgaria, Moldova, Poland, Spain, Ukraine
Outcome results
None listed