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Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716144
First Posted: July 16, 2008
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
July 15, 2008
July 16, 2008
October 12, 2017
June 2006
May 2007   (Final data collection date for primary outcome measure)
PASI75 success at Visit 6 [ Time Frame: Visit 6 (post 12 weeks on treatment) ]
Same as current
Complete list of historical versions of study NCT00716144 on ClinicalTrials.gov Archive Site
  • PASI50 [ Time Frame: each post-baseline visit ]
  • Investigator's Global Assessment [ Time Frame: each post-baseline visit ]
  • PASI75 [ Time Frame: each post-baseline visit except Visit 6 ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
A Randomized, Evaluator-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Study of the Safety and Efficacy of Oral R115866 and R115866 Placebo in the Treatment of Plaque Psoriasis
Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • R115866
  • Rambazole
  • Active Comparator: A
    Talarozole 0.5 mg
    Intervention: Drug: Talarozole
  • Active Comparator: B
    Talarozole 1.0 mg
    Intervention: Drug: Talarozole
  • Active Comparator: C
    Talarozole 2.0 mg
    Intervention: Drug: Talarozole
  • Placebo Comparator: D
    Talarozole matching Placebo
    Intervention: Drug: Talarozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
May 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Plaque Psoriasis with PASI greater than or equal to 10
  • Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy);

Exclusion Criteria:

  • Spontaneously improving or rapidly deteriorating plaque psoriasis
  • Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
  • Subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension)
  • Any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history
  • Previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine
  • Previous use of systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations
  • Previous use of any systemic immunomodulatory therapy known to affect psoriasis and NOT typically to decrease immune cell populations
  • Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within the previous four weeks
  • Pregnant or a nursing mother
  • Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test for human immunodeficiency virus (HIV), a history indicating adrenal cortex dysfunction
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Ireland,   Netherlands,   Russian Federation,   United Kingdom
 
 
NCT00716144
BT0720-201-INT
No
Not Provided
Not Provided
GlaxoSmithKline ( Stiefel, a GSK Company )
Stiefel, a GSK Company
Not Provided
Principal Investigator: Christopher EM Griffiths, MD Hope Hospital, University of Manchester, UK
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP