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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01235442 | Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 592 | — | — | Sep 1, 2010 | Dec 1, 2011 | Aug 7, 2018 | - | — |
The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.
| Arm | Type | Description |
|---|---|---|
| etanercept and clobetasol | EXPERIMENTAL | Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24) |
| etanercept | EXPERIMENTAL | Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks |
| Name | Type | Description |
|---|---|---|
| 1=Etanercept | DRUG | 50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks. |
| 2=Clobetasol propionate foam | DRUG | 0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses |
Inclusion Criteria: * Subject has had stable moderate to severe plaque psoriasis for at least 6 months * Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline. * Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator Exclusion Criteria: ...