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Completed

NCT Number: NCT00236119

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest University, Winston-Salem, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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 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.

Primary outcomes

  1. Physicians Static Global (PSGA) Score

    Time frame: 87 Days

    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.

Secondary outcomes

  1. PSGA Change from Baseline

    Time frame: 87 days

    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

  2. Psoriasis Area and Severity Index (PASI)

    Time frame: 87 Days

    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

Sponsors and collaborators

Lead sponsor

Cephalon

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 12, 2005
Registry last updated
Aug 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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