Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Single very high i.v. dose BI 655066
Single i.v. administration of placebo
Single high s.c. dose BI 655066
1311.1.0007 Boehringer Ingelheim Investigational Site
Burbank, California, United States
1311.1.0008 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1311.1.0003 Boehringer Ingelheim Investigational Site
Port Orange, Florida, United States
Number of patients with good and satisfactory assessment of global tolerability by investigator
Time frame: 24 weeks
Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator
Time frame: up to 1 week
Number of participants with adverse events
Time frame: up to 24 weeks
Number of participants with clinically relevant findings in vital signs
Time frame: up to 24 weeks
Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results
Time frame: up to 24 weeks
Number of participants with significant changes from baseline laboratory measurements
Time frame: up to 24 weeks
Psoriasis Area and Severity Index (absolute score)
Time frame: up to 24 weeks
Percentage of participants with Static Physicians Global Assessment (clear and almost clear)
Time frame: up to 24 weeks
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 24 weeks
tmax (time from dosing to maximum measured concentration)
Time frame: up to 24 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
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Single low i.v. dose BI 655066
Single high medium i.v. dose BI 655066
Single very low i.v. dose BI 655066
Single low s.c. dose BI 655066
Single high i.v. dose BI 655066
Single s.c. administration of placebo
Single low medium i.v. dose BI 655066
1311.1.0005 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
1311.1.0006 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1311.1.0004 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1311.1.0002 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1311.1.4901 Boehringer Ingelheim Investigational Site
Berlin, Germany
1311.1.0009 Boehringer Ingelheim Investigational Site
Leeds, United Kingdom
Time frame: 24 weeks
Psoriasis Area and Severity Index (percentage change from baseline)
Time frame: up to 24 weeks