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Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe Psoriasis
This study has been completed.
Sponsored by: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00236119
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CEP-701
Phase II

MedlinePlus related topics: Psoriasis
Drug Information available for: CEP 701
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Cephalon:

Enrollment: 46
Study Start Date: June 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236119

Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Texas Dermatology Rsch Inst
Dallas, Texas, United States, 75230
United States, Virginia
Viginia Clinical Research
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Cephalon
  More Information

Study ID Numbers: C0701/2024/DR/US
Study First Received: October 11, 2005
Last Updated: February 21, 2008
ClinicalTrials.gov Identifier: NCT00236119  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009