This study is open to adults with plaque psoriasis. The main purpose of this study is to find out whether people with plaque psoriasis can tolerate a medicine called BI 765250. Another purpose is to check whether BI 765250 can improve participants' skin condition. Participants are divided into 5 groups. Each group gets a different dose of BI 765250 or placebo as an infusion or injection for 12 weeks. Placebo infusions and injections look like BI 765250 but do not contain any medicine. It is decided by chance, who gets BI 765250 and who gets placebo. During the first 2 weeks, participants get the study medicine as an infusion into a vein once a week. Afterwards, they get the study medicine as an injection under the skin every 2 or 4 weeks. In total, every participant gets up to 5 injections. Participants are in the study for about 8 months. During this time, they visit the study site 23 times. On 2 of the visits, participants stay overnight at the study site, once for 2 nights and once for 1 night. The doctors collect information on any health problems of the participants. They also regularly check participants' skin condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
BI 765250
placebo
MBAL Sveta Sofia
Sofia, Bulgaria
ARENSIA Exploratory Medicine LLC
Tbilisi, Georgia
Clinical Republican Hospital "Timofei Mosneaga"
Chisinau, Moldova
MONZA Medical Center
Bucharest, Romania
Emergency County Hospital, Arensia EM
Cluj-Napoca, Romania
Occurrence of any adverse events
Time frame: Up to Day 239
Maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: Up to Day 85
Time from last dosing to maximum concentration of the analyte in serum at steady state (tmax,ss)
Time frame: Up to Day 85
Area under the concentration-time curve of the analyte in serum at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: Up to Day 85
Absolute change from baseline in the Static Physician's Global Assessment (sPGA) x Body Surface Area (BSA) score
Time frame: At baseline and at week 12
Percentage change from baseline in the sPGA x BSA score
Time frame: At baseline and at week 12
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