Clinical trial NCT00716144: Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-07-16
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Psoriasis Area Severity Index (PASI)75 Success at Visit 6
timeFrame: Week 12 (Visit 6)
Secondary outcomes:
measure: PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit
timeFrame: Week 1 to Week 20 (Visit 3 to Visit 8)
measure: Investigator's Global Assessment (IGA) at Each Post Baseline Visit
timeFrame: Week 1 to Week 20 (Visit 3 to Visit 8)
measure: PASI75 at Each Post Baseline Visit Except Visit 6
timeFrame: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Dresden
country: Germany
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Salzwedel
country: Germany
facility: GSK Investigational Site
city: Cork
country: Ireland
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Korolev
country: Russian Federation
facility: GSK Investigational Site
city: Lipetsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Aberdeen
country: United Kingdom
facility: GSK Investigational Site
city: Amersham
country: United Kingdom
facility: GSK Investigational Site
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Norwich
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: