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CompletedNCT00725348Updated Sep 26, 2011

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

A Phase 2 interventional study of Talarozole in Psoriasis, sponsored by Stiefel, a GSK Company. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-26.

Sponsored by Stiefel, a GSK Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 19 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    A

    R115866

    Drug: Talarozole

Interventions

  • DrugTalarozole

    1.0 mg oral dose per day

    Also known as: Rambazole, R115866

06

What researchers measure

Primary outcomes

  1. PASI Scores

    Time frame: Various Visits

07

Study locations

2 sites
  • Academisch Ziekenhuis Maastricht
    Maastricht, Netherlands
  • Universitair Medisch Centrum Nijmegen Sint Radboud
    Nijmegen, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00725348
Lead sponsor
Stiefel, a GSK Company
Responsible party
Sponsor
First posted
Jul 30, 2008
Start date
Apr 2004
Primary completion
Mar 2005
Completion
Dec 2006
Last update
Sep 26, 2011

Study contacts

Prof. P. van de Kerkhof, MD, PhD
principal investigator · University of Nijmegen, Maastricht, The Netherlands

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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