Status:
TERMINATED
A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
Lead Sponsor:
Galapagos NV
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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, safe...
Eligibility Criteria
Inclusion
- 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
- 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 exclusion criteria.
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04700267
Start Date
December 28 2020
End Date
October 6 2021
Last Update
October 21 2021
Active Locations (14)
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1
Medical center Medconsult Pleven
Pleven, Bulgaria, 5800
2
UMHAT-Plovdiv AD
Plovdiv, Bulgaria, 4002
3
UMHAT Sv. Ivan Rilski EAD
Sofia, Bulgaria, 1612
4
ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova, 2025