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OpenTrials
Completed

NCT Number: NCT00725348

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Academisch Ziekenhuis Maastricht, Maastricht, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talarozole

Drug

1.0 mg oral dose per day

Other names: Rambazole, R115866

Primary outcomes

  1. PASI Scores

    Time frame: Various Visits

Sponsors and collaborators

Lead sponsor

Stiefel, a GSK Company

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Jul 30, 2008
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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