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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00716144 | Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis | PHASE2 | COMPLETED | 176 | — | — | Jun 1, 2006 | May 1, 2007 | Jan 29, 2018 | 22 | Germany, Ireland +3 |
| NCT00725348 | An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis | PHASE2 | COMPLETED | 19 | — | — | Apr 1, 2004 | Dec 1, 2006 | Sep 26, 2011 | 2 | Netherlands |
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | Talarozole 0.5 mg |
| B | ACTIVE_COMPARATOR | Talarozole 1.0 mg |
| C | ACTIVE_COMPARATOR | Talarozole 2.0 mg |
| D | PLACEBO_COMPARATOR | Talarozole matching Placebo |
| Name | Type | Description |
|---|---|---|
| Talarozole | DRUG | Oral Capsule Once Daily |
Inclusion Criteria: * Plaque Psoriasis with PASI greater than or equal to 10 * Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy); Exclusion Criteria: * Spontaneously improving or rapidly deteriorating plaque p...