Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe Psoriasis

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
Psoriasis
Interventions
DRUG

CEP-701 20mg

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.

DRUG

CEP-701 40mg

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.

DRUG

CEP-701 60mg

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.

DRUG

CEP-701 80mg

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.

Trial Locations (3)

23507

Viginia Clinical Research, Norfolk

27157

Wake Forest University, Winston-Salem

75230

Texas Dermatology Rsch Inst, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY