An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Talarozole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>R115866 | Drug: Talarozole<br>* 1.0 mg oral dose per day<br>* Other names: R115866;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI Scores |  | Various Visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis