The purpose of this research study is to assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG3667 in multiple daily oral doses in subjects with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
MC Comac Medical Ltd.
Sofia, Bulgaria
Early Clinical Trials Unit University Clinical Centre
Gdansk, Poland
Barbara Rewerska Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, Poland
Centrum Medyczne All-Med
Lodz, Poland
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation in subjects with moderate to severe plaque psoriasis.
To evaluate the safety and tolerability of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.
Time frame: From screening through study completion, an average of 3 months
Psoriasis Area and Severity Index (PASI) % change
To evaluate signs of clinical efficacy of GLPG3667 compared to placebo in subjects with moderate to severe plaque psoriasis.
Time frame: At week 4
Observed GLPG3667 plasma trough concentrations (Ctrough).
To characterize the pharmacokinetics (PK) of GLPG3667 in subjects with moderate to severe plaque psoriasis.
Time frame: Between Day 1 pre-dose and Day 30
Change from baseline in interleukin 17 [IL-17] levels between treatment groups and time points.
To evaluate blood pharmacodynamics (PD) markers in response to administration of GLPG3667 in subjects with moderate to severe plaque psoriasis.
Time frame: Between Day 1 pre-dose and Day 60
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Reumed Sp. z o. o.
Lublin, Poland
WIP Warsaw IBD Point
Warsaw, Poland
Summit Clinical Research, s.r.o.
Bratislava, Slovakia