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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 )

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Talarozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : June 1, 2006
Actual Primary Completion Date : May 1, 2007
Actual Study Completion Date : May 1, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Talarozole 0.5 mg
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • Rambazole
  • R115866
Active Comparator: B
Talarozole 1.0 mg
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • Rambazole
  • R115866
Active Comparator: C
Talarozole 2.0 mg
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • Rambazole
  • R115866
Placebo Comparator: D
Talarozole matching Placebo
Drug: Talarozole
Oral Capsule Once Daily
Other Names:
  • Rambazole
  • R115866



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716144


Locations
Germany
GSK Investigational Site
Augsburg, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Dresden, Germany
GSK Investigational Site
Frankfurt, Germany
GSK Investigational Site
Hamburg, Germany
GSK Investigational Site
Salzwedel, Germany
Ireland
GSK Investigational Site
Cork, Ireland
Netherlands
GSK Investigational Site
Maastricht, Netherlands
GSK Investigational Site
Nijmegen, Netherlands
Russian Federation
GSK Investigational Site
Korolev, Russian Federation
GSK Investigational Site
Lipetsk, Russian Federation
GSK Investigational Site
Moscow, Russian Federation
GSK Investigational Site
Novgorod, Russian Federation
GSK Investigational Site
Smolensk, Russian Federation
GSK Investigational Site
St. Petersburg, Russian Federation
GSK Investigational Site
Yaroslavl, Russian Federation
United Kingdom
GSK Investigational Site
Aberdeen, United Kingdom
GSK Investigational Site
Amersham, United Kingdom
GSK Investigational Site
Coventry, United Kingdom
GSK Investigational Site
Glasgow, United Kingdom
GSK Investigational Site
Manchester, United Kingdom
GSK Investigational Site
Norwich, United Kingdom
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00716144     History of Changes
Other Study ID Numbers: BT0720-201-INT
First Posted: July 16, 2008    Key Record Dates
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018
Last Verified: May 2017

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
R 115866
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action