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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00689481 | Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies | PHASE3 | COMPLETED | 323 | — | — | Mar 1, 2008 | Oct 1, 2008 | Oct 7, 2016 | 12 | United States |
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
| Arm | Type | Description |
|---|---|---|
| U0267 foam | EXPERIMENTAL | U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| Vehicle foam | PLACEBO_COMPARATOR | Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| Name | Type | Description |
|---|---|---|
| U0267 Foam | DRUG | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
| Vehicle foam | DRUG | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
Inclusion Criteria: * Male or female subjects at least 12 years old and in good general health. * Mild to moderate plaque-type psoriasis Exclusion Criteria: * Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulatio...