Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis - Full Text View

Sponsor:	Stiefel, a GSK Company
Information provided by (Responsible Party):	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00716144

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 II

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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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 February 09, 2012