- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236119
Study of the Efficacy, Safety and Tolerability of Oral CEP-701 in Patients With Severe Psoriasis
August 22, 2012 updated by: Cephalon
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University
-
-
Texas
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Dallas, Texas, United States, 75230
- Texas Dermatology Rsch Inst
-
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Virginia
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Norfolk, Virginia, United States, 23507
- Viginia Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CEP-701 20mg
Patient Cohort 1
|
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.
|
Experimental: CEP-701 40mg
Patient Cohort 2
|
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.
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.
|
Experimental: CEP-701 60mg
Patient Cohort 3
|
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.
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.
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.
|
Experimental: CEP-701 80mg
Patient Cohort 4
|
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
87 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
87 days
|
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 |
87 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
October 11, 2005
First Submitted That Met QC Criteria
October 11, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
August 23, 2012
Last Update Submitted That Met QC Criteria
August 22, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C0701/2024/DR/US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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