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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00236119 | Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe Psoriasis | PHASE2 | COMPLETED | 46 | — | — | Jun 1, 2005 | Oct 1, 2007 | Aug 23, 2012 | 3 | United States |
The primary objective of the study is to evaluate the efficacy of oral escalating dosages of CEP-701 at 20, 40, 60, and 80 mg given twice daily (bid) in achieving complete or nearly clearing of psoriasis in patients with severe, recalcitrant, plaque-type psoriasis, as assessed by the Physicians Static Global (PSGA) at baseline and at the end of treatment. A PSGA score of 0 is defined as no evidence of plaque elevation, no evidence of erythema, and no evidence of scaling. A PSGA score of 5 is defined as plaque elevation (2.5 mm or greater)dusky to deep red coloration, very thick tenacious scale predominates.
| Arm | Type | Description |
|---|---|---|
| CEP-701 20mg | EXPERIMENTAL | Patient Cohort 1 |
| CEP-701 40mg | EXPERIMENTAL | Patient Cohort 2 |
| CEP-701 60mg | EXPERIMENTAL | Patient Cohort 3 |
| CEP-701 80mg | EXPERIMENTAL | Patient Cohort 4 |
| Name | Type | Description |
|---|---|---|
| CEP-701 20mg | DRUG | Dosages of oral CEP-701 20mg will be given twice daily. Escalation to the next higher dosage, CEP-701 40mg, may occur once the first 8 patients at the current dosage have completed 8 weeks of treatment without adverse events or laboratory abnormalities. Patients who remain in Cohort 1 will continue on the 20mg dosage until study completion. |
| CEP-701 40mg | DRUG | Dosages of oral CEP-701 40mg will be given twice daily.Escalation to the next higher dosage, CEP-701 60mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 2 will continue on the 40mg dosage until study completion. |
| CEP-701 60mg | DRUG | Dosages of oral CEP-701 60mg will be given twice daily. Escalation to the next higher dosage, CEP-701 80mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 3 will continue on the 60mg dosage until study completion. |
| CEP-701 80mg | DRUG | Dosages of oral CEP-701 80mg will be given twice daily. Patients who have moved to Cohort 4 will continue on the 80mg dosage until study completion. |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * the patient is at least 21 years old. * The patient has sever, recalcitrant, plaque-type psoriasis and has failed at least 1 systemic therapy (for the purposes of this study psoralen with ultraviolet...