Status:
COMPLETED
An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis
Lead Sponsor:
Stiefel, a GSK Company
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get active medication, there is no placebo arm.
Eligibility Criteria
Inclusion
- Male or female of non-childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion)
- Presence of moderate to severe plaque psoriasis with a PASI of at least 5
Exclusion
- Pustular, guttate or other non-plaque forms of psoriasis or psoriatic arthritis
- Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
- History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
- Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc \>470 ms in females or \>450 ms in males
- Use of vitamin A (\>1000 µg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroidal anti-inflammatory drugs, non-potassium-sparing diuretics
- Previous use of any systemic immunomodulatory therapy (biologicals) or psoriasis vaccine
- Use of other systemic therapy for psoriasis (e.g. PUVA, systemic steroids, cyclosporin A, methotrexate, retinoids) within four weeks prior to Visit 2
- Use of UV therapy or excessive UV exposure or topical therapy for psoriasis other than bland emollients within two weeks prior to Visit 2
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00725348
Start Date
April 1 2004
End Date
December 1 2006
Last Update
September 26 2011
Active Locations (2)
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1
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
2
Universitair Medisch Centrum Nijmegen Sint Radboud
Nijmegen, Netherlands