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

Cephalon

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: CEP-701 60mg; Drug: CEP-701 40mg; Drug: CEP-701 80mg; Drug: CEP-701 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236119

C0701/2024/DR/US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

CEP-701 20mg

Experimental group

Description:

Patient Cohort 1

Treatment:

Drug: CEP-701 20mg

CEP-701 40mg

Experimental group

Description:

Patient Cohort 2

Treatment:

Drug: CEP-701 40mg

Drug: CEP-701 20mg

CEP-701 60mg

Experimental group

Description:

Patient Cohort 3

Treatment:

Drug: CEP-701 60mg

Drug: CEP-701 40mg

Drug: CEP-701 20mg

CEP-701 80mg

Experimental group

Description:

Patient Cohort 4

Treatment:

Drug: CEP-701 60mg

Drug: CEP-701 40mg

Drug: CEP-701 20mg

Drug: CEP-701 80mg