Clinical trial NCT00236119: Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe Psoriasis
Official title: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 light A is considered to be a systemic therapy).
* The patient has psoriatic involvement of at least 10% of BSA.
* The patient has a PSGA score of 4 or greater.
* The patient, if a woman, is surgically sterile or 2 years postmenopausal, or if of childbearing potential is currently using a medically accepted method of contraception, and agrees to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device (IUD).
* The patient, if a main, is surgically sterile, or if capable of producing offspring, is currently using an approved method of birth control, and agrees to continued use of this method for the duration of the study (and for 60 days after taking the last dose of CEP-701 because of the possible effects on spermatogenesis).
* The patient must be willing and able to comply with study procedures and restrictions and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

* The patient has received treatment with systemic psoriasis treatments (specifically, retinoids, methotrexate, cyclosporine A, etanercept, efalizumab, other biological agents or other immunomodulators) within 4 weeks, or UV based therapy within 2 weeks, or alefacept within 6 weeks of the planned 1st day of study treatment.
* The patient has received treatment with potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, and troleandomycin, human immunodeficiency virus (HIV) protease inhibitors, or nefazodone within 1 week (7 days) of the planned 1st day of study treatment.
* The patient is currently receiving warfarin.
* The patient has hypersensitivity to CEP-701 or any component of CEP-701.
* The patient has one or more of the following serum chemistry values as determined at the screening visit (visit 1):
* bilirubin levels greater than 2 times the upper limit of normal (ULN)
* ALT or AST levels greater than 2 times the ULN
* serum creatinine levels or more than 2mg/dL
* The patient requires current treatment for HIV with protease inhibitors.
* The patient is taking medication for a clinical diagnosis of gastrointestinal ulceration or has experienced melena or hematoemesis in the previous 3 weeks.
* The patient is a woman who is pregnant or lactating.
* The patient has received treatment with an investigation drug within 4 weeks of the planned 1st day of study treatment.

Primary outcomes:
measure: Physicians Static Global (PSGA) Score
timeFrame: 87 Days
Secondary outcomes:
measure: PSGA Change from Baseline
timeFrame: 87 days
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: 87 Days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Dallas
country: United States
facility: Texas Dermatology Rsch Inst
state: Texas
city: Norfolk
country: United States
facility: Viginia Clinical Research
state: Virginia
Study officials:
References: