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

NCT00236119 | Completed Phase 2

• 1 other identifier: C0701/2024/DR/US
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  87 Days

Secondary Outcomes (2)

• PSGA Change from Baseline

  87 days

• Psoriasis Area and Severity Index (PASI)

  87 Days

Study Arms (4)

CEP-701 20mg

EXPERIMENTAL

Patient Cohort 1

Drug: CEP-701 20mg

CEP-701 40mg

EXPERIMENTAL

Patient Cohort 2

Drug: CEP-701 20mg; Drug: CEP-701 40mg

CEP-701 60mg

EXPERIMENTAL

Patient Cohort 3

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

CEP-701 80mg

EXPERIMENTAL

Patient Cohort 4

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

Interventions

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 20mg; CEP-701 40mg; CEP-701 60mg; CEP-701 80mg

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 40mg; CEP-701 60mg; CEP-701 80mg

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 60mg; CEP-701 80mg

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.

CEP-701 80mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (3)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Texas Dermatology Rsch Inst

Dallas, Texas, 75230, United States

Location

Viginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

lestaurtinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

US (3)