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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00716144
First received: July 15, 2008
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Talarozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PASI75 success at Visit 6 [ Time Frame: Visit 6 (post 12 weeks on treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PASI50 [ Time Frame: each post-baseline visit ] [ Designated as safety issue: No ]
  • Investigator's Global Assessment [ Time Frame: each post-baseline visit ] [ Designated as safety issue: No ]
  • PASI75 [ Time Frame: each post-baseline visit except Visit 6 ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Talarozole 0.5 mg
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • R115866
  • Rambazole
Active Comparator: B
Talarozole 1.0 mg
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • R115866
  • Rambazole
Active Comparator: C
Talarozole 2.0 mg
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • R115866
  • Rambazole
Placebo Comparator: D
Talarozole matching Placebo
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • R115866
  • Rambazole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716144

Locations
Germany
Private Practice
Augsburg, Germany
Private Practice
Berlin, Germany
Psoriasis Studienzentrum
Berlin, Germany
Private Practice
Dresden, Germany
Klinikum der J.W. Goethe Universität
Frankfurt, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
Private Practice
Salzwedel, Germany
Ireland
South Infirmary Victoria Hospital
Cork, Ireland
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
UMC St. Radboud
Nijmegen, Netherlands
Russian Federation
Municipal Medical Preventive Institute
Korolev, Russian Federation
Municipal Institution of Public Health Services
Lipetsk, Russian Federation
Municipal Institution of Public Health
Moscow, Russian Federation
State Educational Establishment of Higher Professional Education Russian State Medical University of Roszdrav
Moscow, Russian Federation
Federal State Institution
Novgorod, Russian Federation
Regional State Establishment of Public Health Services
Smolensk, Russian Federation
The State Institution of Higher Professional Education Military Medical Academy
St. Petersburg, Russian Federation
Municipal Institute of Public Health Service
Yaroslavl, Russian Federation
United Kingdom
Dermatology Out-Patient Clinic
Aberdeen, United Kingdom
Amersham Hospital
Amersham, United Kingdom
George Eliot Hospital
Coventry, United Kingdom
Western Infirmary
Glasgow, United Kingdom
Hope Hospital, University of Manchester
Manchester, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Sponsors and Collaborators
Stiefel, a GSK Company
Investigators
Principal Investigator: Christopher EM Griffiths, MD Hope Hospital, University of Manchester, UK
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00716144     History of Changes
Other Study ID Numbers: BT0720-201-INT
Study First Received: July 15, 2008
Last Updated: September 23, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Psoriasis

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

ClinicalTrials.gov processed this record on April 17, 2014