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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
GLPG3970 for oral administration
Placebo for oral administration
Medical center Medconsult Pleven
Pleven, Bulgaria
UMHAT-Plovdiv AD
Plovdiv, Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, Bulgaria
Change in biomarkers associated with disease anti-dsDNA
To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Time frame: Between Day 1 and 104
Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)
To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Time frame: Between Day 1 and 104
Number, incidence, and severity of treatment-emergent adverse events (TEAEs)
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE
Time frame: From screening through study completion, an average of 5 months
Observed GLPG3970 plasma trough concentrations (Ctrough)
To characterize the PK of GLPG3970 in adult subjects with active SLE
Time frame: Between Day 1 and 87
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ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Centrum Medyczne Plejady
Krakow, Poland
Medycyna Kliniczna
Warsaw, Poland
FutureMeds sp. Z o. o.
Wroclaw, Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Medical Centre of Ltd Liability Comp
Kyiv, Ukraine
...and 4 more locations