BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
- Registration Number
- NCT02054481
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 BI 655066 BI 655066 s.c. Arm 1 BI 655066 BI 655066 s.c. Arm 3 BI 655066 BI 655066 s.c. Arm 4 Ustekinumab Ustekinumab s.c.
- Primary Outcome Measures
Name Time Method Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 Baseline and 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).
- Secondary Outcome Measures
Name Time Method Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12 Baseline and 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).Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12 Baseline and 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).Achievement of PASI90 at Week 24 Week 24 Percentage of participants who achieved PASI90 at Week 24.
PASI score ranges from 0 (best) to 72 (worst).Percentage Change in PASI Score From Baseline at Week 12 Baseline and 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).Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24 Baseline, Week 12 and Week 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).Achievement of sPGA Clear or Almost Clear at Week 12 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 to Loss of PASI50 Response From first drug administration until end of follow-up period, up to 48 weeks Time to loss of PASI50 response.
Trial Locations
- Locations (32)
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
Scroll for more (22 remaining)1311.2.10010 Boehringer Ingelheim Investigational Site🇺🇸Los Angeles, California, United States