Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01577550 | Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis | PHASE1 | COMPLETED | 39 | — | — | Apr 1, 2012 | May 1, 2014 | Nov 16, 2016 | 9 | United States, Germany +1 |
| Arm | Type | Description |
|---|---|---|
| i.v. BI 655066 | EXPERIMENTAL | A subject to receive a single i.v. dose of BI 655066 |
| i.v. placebo | PLACEBO_COMPARATOR | A subject to receive a single i.v. dose of placebo |
| s.c. BI 655066 | EXPERIMENTAL | A subject to receive a single s.c. dose of BI 655066 |
| s.c. placebo | PLACEBO_COMPARATOR | A subject to receive a single s.c. dose of placebo |
| Name | Type | Description |
|---|---|---|
| BI 655066 (very high i.v. dose) | DRUG | Single very high i.v. dose BI 655066 |
| Placebo, i.v. | DRUG | Single i.v. administration of placebo |
| BI 655066 (high s.c. dose) | DRUG | Single high s.c. dose BI 655066 |
| BI 655066 (low i.v. dose) | DRUG | Single low i.v. dose BI 655066 |
| BI 655066 (high medium i.v. dose) | DRUG | Single high medium i.v. dose BI 655066 |
| BI 655066 (very low i.v. dose) | DRUG | Single very low i.v. dose BI 655066 |
| BI 655066 (low s.c. dose) | DRUG | Single low s.c. dose BI 655066 |
| BI 655066 (high i.v. dose) | DRUG | Single high i.v. dose BI 655066 |
| Placebo, s.c. | DRUG | Single s.c. administration of placebo |
| BI 655066 (low medium i.v. dose) | DRUG | Single low medium i.v. dose BI 655066 |
Inclusion criteria: 1. Male or female patients aged 18-75 years (inclusive) 2. Chronic moderate to severe plaque psoriasis lasting =\>6 months with involvement of Body Surface Area (BSA) =\>10%, Psoriasis Area and Severity Index (PASI) =\>12 and Static Physician Global Assessment (sPGA) score of mo...