Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis
- Conditions
- Psoriasis
- Interventions
- Drug: BI 655066 (very high i.v. dose)Drug: Placebo, i.v.Drug: Placebo, s.c.Drug: BI 655066 (high s.c. dose)Drug: BI 655066 (low i.v. dose)Drug: BI 655066 (low s.c. dose)Drug: BI 655066 (high medium i.v. dose)Drug: BI 655066 (very low i.v. dose)Drug: BI 655066 (high i.v. dose)Drug: BI 655066 (low medium i.v. dose)
- Registration Number
- NCT01577550
- Lead Sponsor
- AbbVie
- Brief Summary
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description i.v. BI 655066 BI 655066 (very high i.v. dose) A subject to receive a single i.v. dose of BI 655066 i.v. BI 655066 BI 655066 (low i.v. dose) A subject to receive a single i.v. dose of BI 655066 i.v. BI 655066 BI 655066 (very low i.v. dose) A subject to receive a single i.v. dose of BI 655066 i.v. BI 655066 BI 655066 (high i.v. dose) A subject to receive a single i.v. dose of BI 655066 i.v. BI 655066 BI 655066 (high medium i.v. dose) A subject to receive a single i.v. dose of BI 655066 i.v. BI 655066 BI 655066 (low medium i.v. dose) A subject to receive a single i.v. dose of BI 655066 i.v. placebo Placebo, i.v. A subject to receive a single i.v. dose of placebo s.c. placebo Placebo, s.c. A subject to receive a single s.c. dose of placebo s.c. BI 655066 BI 655066 (high s.c. dose) A subject to receive a single s.c. dose of BI 655066 s.c. BI 655066 BI 655066 (low s.c. dose) A subject to receive a single s.c. dose of BI 655066
- Primary Outcome Measures
Name Time Method Number of patients with good and satisfactory assessment of global tolerability by investigator 24 weeks Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator up to 1 week Number of participants with adverse events up to 24 weeks Number of participants with clinically relevant findings in vital signs up to 24 weeks Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results up to 24 weeks Number of participants with significant changes from baseline laboratory measurements up to 24 weeks
- Secondary Outcome Measures
Name Time Method tmax (time from dosing to maximum measured concentration) 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) 24 weeks Psoriasis Area and Severity Index (percentage change from baseline) up to 24 weeks Psoriasis Area and Severity Index (absolute score) up to 24 weeks Percentage of participants with Static Physicians Global Assessment (clear and almost clear) up to 24 weeks Cmax (maximum measured concentration of the analyte in plasma) up to 24 weeks
Trial Locations
- Locations (9)
1311.1.0007 Boehringer Ingelheim Investigational Site
🇺🇸Burbank, California, United States
1311.1.4901 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1311.1.0003 Boehringer Ingelheim Investigational Site
🇺🇸Port Orange, Florida, United States
1311.1.0006 Boehringer Ingelheim Investigational Site
🇺🇸Evansville, Indiana, United States
1311.1.0002 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
1311.1.0009 Boehringer Ingelheim Investigational Site
🇬🇧Leeds, United Kingdom
1311.1.0004 Boehringer Ingelheim Investigational Site
🇺🇸North Dartmouth, Massachusetts, United States
1311.1.0008 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1311.1.0005 Boehringer Ingelheim Investigational Site
🇺🇸Normal, Illinois, United States