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

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ClinicalTrials.gov Identifier: NCT00716144
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

July 15, 2008
July 16, 2008
March 10, 2017
January 29, 2018
January 29, 2018
June 1, 2006
May 1, 2007   (Final data collection date for primary outcome measure)
Psoriasis Area Severity Index (PASI)75 Success at Visit 6 [ Time Frame: Week 12 (Visit 6) ]
PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
PASI75 success at Visit 6 [ Time Frame: Visit 6 (post 12 weeks on treatment) ]
Complete list of historical versions of study NCT00716144 on ClinicalTrials.gov Archive Site
  • PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit [ Time Frame: Week 1 to Week 20 (Visit 3 to Visit 8) ]
    PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
  • Investigator's Global Assessment (IGA) at Each Post Baseline Visit [ Time Frame: Week 1 to Week 20 (Visit 3 to Visit 8) ]
    The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.
  • PASI75 at Each Post Baseline Visit Except Visit 6 [ Time Frame: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6) ]
    PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.
  • 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 ]
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:
  • Rambazole
  • R115866
  • 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
Same as current
May 1, 2007
May 1, 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, Older Adult)
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
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017

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