A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type Psoriasis.
A 12-Week, Exploratory, Open-Label, Nonrandomized, Dose-Escalation Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients with Severe, Recalcitrant, Plaque Type Psoriasis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
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.
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.
Wake Forest University
Winston-Salem, North Carolina, United States
Texas Dermatology Rsch Inst
Dallas, Texas, United States
Viginia Clinical Research
Norfolk, Virginia, United States
Physicians Static Global (PSGA) Score
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.
Time frame: 87 Days
PSGA Change from Baseline
Change from baseline to the end of treatment (ie, day 85±2 PSGA measured on a scale of 0 to 5 at the end of treatment severity of itch measured on a severity scale of 0 to 5 at the 85±2 days) 0 meaning No itching - 5 Severe; constant itching; distressing; frequent disturbance of sleep; interferes with activities
Time frame: 87 days
Psoriasis Area and Severity Index (PASI)
Psoriasis Area and Severity Index (PASI) 0=no involvement 1=\<10% involvement 2=10% to \<30% involvement 3=30% to \<50% involvement 4=50% to \<70% involvement 5=70% to \<90% involvement 6=90% to 100% involvement
Time frame: 87 Days
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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.