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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Talarozole 0.5 mg |
|
| B | Active Comparator | Talarozole 1.0 mg |
|
| C | Active Comparator | Talarozole 2.0 mg |
|
| D | Placebo Comparator | Talarozole matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talarozole | Drug | Oral Capsule Once Daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area Severity Index (PASI)75 Success at 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. | Week 12 (Visit 6) |
| Measure | Description | Time Frame |
|---|---|---|
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Augsburg | Germany | ||||
| GSK Investigational Site |
All participants were screened (Visit 1) two weeks prior to randomization (Visit 2) in order to evaluate their eligibility for entry into the trial. At Visit 1, participants signed an informed consent, provided their medical histories, reported their concomitant medication usages, and were evaluated against the inclusion/exclusion criteria.
A total of 176 participants were randomized into the study. This study was conducted at 25 centers located in Ireland, the United Kingdom, the Netherlands, Germany, and Russia from 19 June 2006 to 18 May 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| FG001 | R115866 0.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 1 to Week 20 (Visit 3 to Visit 8) |
| Investigator's Global Assessment (IGA) at Each Post Baseline Visit | 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. | Week 1 to Week 20 (Visit 3 to Visit 8) |
| PASI75 at Each Post Baseline Visit Except 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. | Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6) |
| Berlin |
| Germany |
| GSK Investigational Site | Dresden | Germany |
| GSK Investigational Site | Frankfurt | Germany |
| GSK Investigational Site | Hamburg | Germany |
| GSK Investigational Site | Hansestadt Salzwedel | Germany |
| GSK Investigational Site | Cork | Ireland |
| GSK Investigational Site | Maastricht | Netherlands |
| GSK Investigational Site | Nijmegen | Netherlands |
| GSK Investigational Site | Korolyov | Russia |
| GSK Investigational Site | Lipetsk | Russia |
| GSK Investigational Site | Moscow | Russia |
| GSK Investigational Site | Saint Petersburg | Russia |
| GSK Investigational Site | Smolensk | Russia |
| GSK Investigational Site | Veliky Novgorod | Russia |
| GSK Investigational Site | Yaroslavl | Russia |
| 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 |
Eligible participants received R115866 softgel capsule 0.5 milligram (mg) orally, one capsule daily each morning with a meal for the 12 week treatment period.
| FG002 | R115866 1.0 mg | Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| FG003 | R115866 2.0 mg | Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| BG001 | R115866 0.5 mg | Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| BG002 | R115866 1.0 mg | Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| BG003 | R115866 2.0 mg | Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psoriasis Area Severity Index (PASI)75 Success at 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. | Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit). | Posted | Number | Participants | Week 12 (Visit 6) |
|
|
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| Secondary | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | 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. | MITT population. | Posted | Number | Participants | Week 1 to Week 20 (Visit 3 to Visit 8) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | 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. | MITT population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the MITT Population. | Posted | Number | Participants | Week 1 to Week 20 (Visit 3 to Visit 8) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PASI75 at Each Post Baseline Visit Except 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. | MITT population. | Posted | Number | Participants | Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6) |
|
Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from Week 1 (Visit 3 [the first, post-randomization study visit]) to Week 20 (Visit 8 or early discontinuation), that is for 20 weeks.
SAEs and nSAEs are reported for the MITT population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period. | 0 | 41 | 1 | 41 | 20 | 41 |
| EG001 | R115866 0.5 mg | Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. | 0 | 45 | 1 | 45 | 34 | 45 |
| EG002 | R115866 1.0 mg | Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. | 0 | 45 | 0 | 45 | 38 | 45 |
| EG003 | R115866 2.0 mg | Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. | 0 | 45 | 0 | 45 | 37 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C406527 | R 115866 |
Not provided
Not provided
Not provided
| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | R115866 1.0 mg | Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| OG003 | R115866 2.0 mg | Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
|
|
|
| R115866 0.5 mg |
Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| OG002 | R115866 1.0 mg | Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| OG003 | R115866 2.0 mg | Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
|
|
| OG002 | R115866 1.0 mg | Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
| OG003 | R115866 2.0 mg | Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period. |
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