Psoriasis
Conditions
Keywords
Psoriasis
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.
Interventions
DRUGTalarozole
Oral Capsule Once Daily
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | 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
| Measure | Time frame | Description |
|---|---|---|
| PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | 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 | 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 | 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. |
Countries
Germany, Ireland, Netherlands, Russia, United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period. | 41 |
| 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. | 45 |
| 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. | 45 |
| 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. | 45 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 2 |
| Overall Study | Adverse event: left foot pain | 0 | 1 | 0 | 0 |
| Overall Study | Clinical Depression | 0 | 1 | 0 | 0 |
| Overall Study | Intercurrent illness | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 2 |
| Overall Study | Non-compliance | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 2 | 2 |
| Overall Study | Protocol Violation | 2 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 6 | 6 |
| Overall Study | Withdrew consent, allowed use of data | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | R115866 2.0 mg | Total | Placebo | R115866 0.5 mg | R115866 1.0 mg |
|---|---|---|---|---|---|
| Age, Continuous | 48.2 Years STANDARD_DEVIATION 12.4 | NA Years | 45.9 Years STANDARD_DEVIATION 12.3 | 42.3 Years STANDARD_DEVIATION 13.3 | 47.3 Years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 174 Participants | 40 Participants | 45 Participants | 44 Participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 4 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 39 Participants | 161 Participants | 37 Participants | 43 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 45 | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 20 / 41 | 34 / 45 | 38 / 45 | 37 / 45 |
| serious Total, serious adverse events | 1 / 41 | 1 / 45 | 0 / 45 | 0 / 45 |
Outcome results
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.
Time frame: Week 12 (Visit 6)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | 4 Participants |
| R115866 0.5 mg | Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | 7 Participants |
| R115866 1.0 mg | Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | 4 Participants |
| R115866 2.0 mg | Psoriasis Area Severity Index (PASI)75 Success at Visit 6 | 5 Participants |
p-value: 0.884Cochran-Armitage Trend Test
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.
Time frame: Week 1 to Week 20 (Visit 3 to Visit 8)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 5 | 15 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 5 | 21 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 3 | 0 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 6 | 17 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 3 | 8 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 5 | 0 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 3 | 27 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 8 | 3 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 3 | 6 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 4 | 0 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 6 | 2 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 4 | 22 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 5 | 3 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 7 | 0 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 6 | 1 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 7 | 5 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 7 | 15 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 5 | 2 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 4 | 4 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 7 | 13 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 7 | 1 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 6 | 3 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 8 | 1 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 4 | 15 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 8 | 6 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 8 | 15 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 6 | 18 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 4 | 0 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 8 | 10 Participants |
| Placebo | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 3 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 6 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 4 | 3 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 8 | 10 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 3 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 7 | 19 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 5 | 21 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 8 | 6 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 3 | 7 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 6 | 12 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 5 | 21 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 6 | 24 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 3 | 31 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 5 | 1 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 4 | 28 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 8 | 21 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 3 | 7 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 5 | 2 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 7 | 1 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 4 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 4 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 6 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 7 | 8 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 4 | 14 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 8 | 1 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 8 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 7 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 6 | 9 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 5 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 3 | 0 Participants |
| R115866 0.5 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 7 | 11 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 5 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 5 | 25 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 5 | 2 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 6 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 6 | 18 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 6 | 1 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 7 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 7 | 8 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 7 | 16 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 7 | 11 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 7 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 8 | 2 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 8 | 9 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 8 | 10 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 8 | 12 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 3 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 3 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 3 | 12 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 3 | 30 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 3 | 3 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 4 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 4 | 0 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 4 | 19 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 4 | 22 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 5 | 15 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 4 | 4 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 5 | 3 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 6 | 6 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 6 | 20 Participants |
| R115866 1.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 8 | 1 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 5 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 5 | 3 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 5 | 18 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 3 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 3 | 5 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 8 | 8 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 4 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 8 | 10 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 4 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 8 | 2 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 7 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 7 | 14 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 7 | 14 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 7 | 8 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 7 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 6 | 3 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 6 | 9 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 8 | 15 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 5 | 6 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 6 | 22 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 6 | 11 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Clear; Visit 6 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 5 | 18 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 4 | 18 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 3 | 25 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 8 | 0 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Moderate; Visit 4 | 24 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Severe; Visit 4 | 3 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Mild; Visit 3 | 15 Participants |
| R115866 2.0 mg | Investigator's Global Assessment (IGA) at Each Post Baseline Visit | Almost clear; Visit 3 | 0 Participants |
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.
Time frame: Week 1 to Week 20 (Visit 3 to Visit 8)
Population: MITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 7 | 11 Participants |
| Placebo | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 6 | 8 Participants |
| Placebo | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 4 | 2 Participants |
| Placebo | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 5 | 7 Participants |
| Placebo | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 3 | 0 Participants |
| Placebo | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 8 | 15 Participants |
| R115866 0.5 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 5 | 9 Participants |
| R115866 0.5 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 4 | 0 Participants |
| R115866 0.5 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 6 | 18 Participants |
| R115866 0.5 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 7 | 18 Participants |
| R115866 0.5 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 8 | 16 Participants |
| R115866 0.5 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 3 | 0 Participants |
| R115866 1.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 7 | 17 Participants |
| R115866 1.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 5 | 8 Participants |
| R115866 1.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 3 | 0 Participants |
| R115866 1.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 6 | 18 Participants |
| R115866 1.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 8 | 18 Participants |
| R115866 1.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 4 | 1 Participants |
| R115866 2.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 5 | 11 Participants |
| R115866 2.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 7 | 21 Participants |
| R115866 2.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 8 | 24 Participants |
| R115866 2.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 4 | 1 Participants |
| R115866 2.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 3 | 0 Participants |
| R115866 2.0 mg | PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit | Visit 6 | 19 Participants |
Comparison: At Visit 3p-value: 1Cochran-Armitage Trend Test
Comparison: At Visit 4p-value: 0.604Cochran-Armitage Trend Test
Comparison: At Visit 5p-value: 0.463Cochran-Armitage Trend Test
Comparison: At Visit 6p-value: 0.042Cochran-Armitage Trend Test
Comparison: At Visit 7p-value: 0.034Cochran-Armitage Trend Test
Comparison: At Visit 8p-value: 0.019Cochran-Armitage Trend Test
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.
Time frame: Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)
Population: MITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 4 | 0 Participants |
| Placebo | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 5 | 4 Participants |
| Placebo | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 7 | 5 Participants |
| Placebo | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 8 | 6 Participants |
| Placebo | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 3 | 0 Participants |
| R115866 0.5 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 7 | 8 Participants |
| R115866 0.5 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 8 | 7 Participants |
| R115866 0.5 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 3 | 0 Participants |
| R115866 0.5 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 5 | 0 Participants |
| R115866 0.5 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 4 | 0 Participants |
| R115866 1.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 7 | 6 Participants |
| R115866 1.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 4 | 1 Participants |
| R115866 1.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 5 | 2 Participants |
| R115866 1.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 8 | 10 Participants |
| R115866 1.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 3 | 0 Participants |
| R115866 2.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 5 | 5 Participants |
| R115866 2.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 4 | 0 Participants |
| R115866 2.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 3 | 0 Participants |
| R115866 2.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 7 | 7 Participants |
| R115866 2.0 mg | PASI75 at Each Post Baseline Visit Except Visit 6 | Visit 8 | 13 Participants |
Comparison: At Visit 3p-value: 1Cochran-Armitage Trend Test
Comparison: At Visit 4p-value: 0.673Cochran-Armitage Trend Test
Comparison: At Visit 5p-value: 0.55Cochran-Armitage Trend Test
Comparison: At Visit 7p-value: 0.721Cochran-Armitage Trend Test
Comparison: At Visit 8p-value: 0.03Cochran-Armitage Trend Test