The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Time frame: Baseline and Week 12
Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24. PASI score ranges from 0 (best) to 72 (worst).
Time frame: Baseline, Week 12 and Week 24
Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12
Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Time frame: Baseline and Week 12
Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12
Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Time frame: Baseline and Week 12
Achievement of PASI90 at Week 24
Percentage of participants who achieved PASI90 at Week 24. PASI score ranges from 0 (best) to 72 (worst).
Time frame: Week 24
Percentage Change in PASI Score From Baseline at Week 12
Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12. PASI score ranges from 0 (best) to 72 (worst).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Low dose
1311.2.10010 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1311.2.10013 Boehringer Ingelheim Investigational Site
Port Orange, Florida, United States
1311.2.10003 Boehringer Ingelheim Investigational Site
Arlington Hts, Illinois, United States
1311.2.10002 Boehringer Ingelheim Investigational Site
Bay City, Michigan, United States
1311.2.10004 Boehringer Ingelheim Investigational Site
Fridley, Minnesota, United States
1311.2.10001 Boehringer Ingelheim Investigational Site
East Windsor, New Jersey, United States
1311.2.10009 Boehringer Ingelheim Investigational Site
Verona, New Jersey, United States
1311.2.10007 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1311.2.10005 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1311.2.10006 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
...and 22 more locations
Time frame: Baseline and Week 12
Achievement of sPGA Clear or Almost Clear at Week 12
Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12. sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe).
Time frame: Week 12
Time to Loss of PASI50 Response
Time to loss of PASI50 response.
Time frame: From first drug administration until end of follow-up period, up to 48 weeks