Trial | NCT00725348  Report issue

Title

An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis
An Open-Label, Multi-Center Pilot Trial to Assess the Efficacy and Safety of Oral R115866 in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    talarozole ...

  • Study Participants

    19
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.
Study Started
Apr 30
2004
Primary Completion
Mar 31
2005
Study Completion
Dec 31
2006
Last Update
Sep 26
2011
Estimate

Drug Talarozole

1.0 mg oral dose per day

  • Other names: Rambazole, R115866

A Experimental

R115866

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted