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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00601107 | A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis | PHASE2 | COMPLETED | 111 | — | — | Apr 1, 2008 | Jun 1, 2009 | May 5, 2014 | 19 | United States |
PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (\<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema \[E\], induration \[I\], and desquamation \[D\]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E\[h\] + I\[h\] + D\[h\]) A\[h\] + 0.2 (E\[u\] + I\[u\] + D\[u\]) A\[u\] + 0.3 (E\[t\] + I\[t\] + D\[t\]) A\[t\] + 0.4 (E\[l\] + l\[I\] + D\[l\]) A\[l\].
| Arm | Type | Description |
|---|---|---|
| Doxercalciferol 2.5 mcg/day | EXPERIMENTAL | Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. |
| Doxercalciferol 5 mcg/day | EXPERIMENTAL | Doxercalciferol 5 mcg capsules orally once daily up to Week 24. |
| Doxercalciferol 7.5 mcg/day | EXPERIMENTAL | Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. |
| Placebo | PLACEBO_COMPARATOR | Placebo matching to doxercalciferol capsules orally once daily up to Week 24. |
| Name | Type | Description |
|---|---|---|
| Doxercalciferol | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Participant had moderate to severe chronic plaque psoriasis defined by a body surface area (BSA) involvement greater than or equal to (\>=) 10 percent (%) and plaques with at least a slight elevation above the surrounding normal skin at the Day 1 visit * Participant had a stat...