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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725348
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Talarozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2004
Primary Completion Date : March 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Drug: Talarozole
1.0 mg oral dose per day
Other Names:
  • Rambazole
  • R115866

Primary Outcome Measures :
  1. PASI Scores [ Time Frame: Various Visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725348

Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Universitair Medisch Centrum Nijmegen Sint Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Stiefel, a GSK Company
Principal Investigator: Prof. P. van de Kerkhof, MD, PhD University of Nijmegen, Maastricht, The Netherlands

Responsible Party: Stiefel, a GSK Company Identifier: NCT00725348     History of Changes
Other Study ID Numbers: BT0700NED001
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: July 2008

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
R 115866
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action