A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus

  • End date
    Mar 22, 2022
  • participants needed
  • sponsor
    Galapagos NV
Updated on 22 August 2021
cutaneous lupus


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.

Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases
Treatment GLPG3970 film-coated tablet, Placebo film-coated tablet
Clinical Study IdentifierNCT04700267
SponsorGalapagos NV
Last Modified on22 August 2021


Yes No Not Sure

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
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
Sjgren'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
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