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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00725348
First received: July 17, 2008
Last updated: September 23, 2011
Last verified: July 2008
  Purpose

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 Intervention Phase
Psoriasis
Drug: Talarozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PASI Scores [ Time Frame: Various Visits ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2004
Study Completion Date: December 2006
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
R115866
Drug: Talarozole
1.0 mg oral dose per day
Other Names:
  • Rambazole
  • R115866

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725348

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

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00725348     History of Changes
Other Study ID Numbers: BT0700NED001
Study First Received: July 17, 2008
Last Updated: September 23, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014