Plaque Psoriasis, Psoriatic Arthritis, Psoriatic Erythroderma, Pustular Psoriasis (Excluding a Localized)
Conditions
Keywords
Infliximab, REMICADE, TA-650, psoriasis
Brief summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.
Detailed description
* Patients with plaque psoriasis or psoriatic arthritis: 1. Screening Period: TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours. 2. Increased Dose Period: If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours. * Patients with pustular psoriasis or psoriatic erythroderma: TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.
Interventions
DRUGTA-650
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma. * Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.
Exclusion criteria
* Patients who have guttate psoriasis. * Patients who have drug-induced psoriasis * Patients who have previously used any other biological products than infliximab. * Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization. * Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections * Female patients who are pregnant, breast-feeding, or possibly pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions. |
| Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions. 0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe |
| Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | From 0 (best) to 100 (worst) |
| Assessment of Severity (Only for Patients With Pustular Psoriasis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | From 0 (best) to 17 (worst) |
Countries
Japan
Participant flow
Pre-assignment details
Patients of Pustular Psoriasis and Psoriatic Erythroderma could directly receive doses of TA-650 10mg per 1kg not to go though screening period.
Participants by arm
| Arm | Count |
|---|---|
| Plaque Psoriasis From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. | 31 |
| Psoriatic Arthritis From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. | 8 |
| Pustular Psoriasis From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. | 7 |
| Psoriatic Erythroderma From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. | 5 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Increased Dose Period | Adverse Event | 6 |
| Increased Dose Period | Withdrawal by Subject | 2 |
| Screening Period | Not meet criteria for dose-up period | 7 |
Baseline characteristics
| Characteristic | Plaque Psoriasis | Psoriatic Arthritis | Pustular Psoriasis | Psoriatic Erythroderma | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 13.9 | 50.1 years STANDARD_DEVIATION 11.9 | 36.7 years STANDARD_DEVIATION 9.7 | 55.8 years STANDARD_DEVIATION 12.5 | 49.5 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 25 Participants | 5 Participants | 4 Participants | 4 Participants | 38 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants | 1 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 46 | 19 / 36 | 5 / 10 | 47 / 51 | 30 / 31 | 7 / 8 | 6 / 7 | 4 / 5 | 34 / 36 | 9 / 10 |
| serious Total, serious adverse events | 0 / 46 | 0 / 36 | 0 / 10 | 5 / 51 | 4 / 31 | 0 / 8 | 1 / 7 | 0 / 5 | 4 / 36 | 0 / 10 |
Outcome results
Primary
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 50.0 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 63.6 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 47.7 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 40.0 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 36.7 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 44.2 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 45.5 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 18.0 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 31.3 percentage of participants |
| Overall | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 13.7 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 34.5 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 40.7 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 53.6 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 16.1 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 42.3 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 16.1 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 38.5 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 40.0 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 30.8 percentage of participants |
| Plaque Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 69.2 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 14.3 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 0.0 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 0.0 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 0.0 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 42.9 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 28.6 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 42.9 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 28.6 percentage of participants |
| Psoriatic Arthritis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 42.9 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 33.3 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 83.3 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 50.0 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 80.0 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 50.0 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 33.3 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 66.7 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 50.0 percentage of participants |
| Pustular Psoriasis | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 50.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 0.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 40.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 60.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 40.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 80.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 60.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 80.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 40.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 80.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 40.0 percentage of participants |
| Psoriatic Erythroderma | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 80.0 percentage of participants |
Secondary
Assessment of Severity (Only for Patients With Pustular Psoriasis)
From 0 (best) to 17 (worst)
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 0 (n=7) | 4.0 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 4 (n=7) | 3.0 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 8 (n=6) | 1.5 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 12 (n=6) | 1.5 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 16 (n=6) | 1.5 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 20 (n=6) | 2.0 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 24 (n=6) | 2.0 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 28 (n=6) | 1.0 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 32 (n=6) | 1.5 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 36 (n=6) | 1.0 units on a scale |
| Overall | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Week 40 (n=5) | 1.0 units on a scale |
Secondary
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions. 0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 0 (n=31) | 0.0 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 4 (n=31) | 32.3 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 8 (n=31) | 32.3 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 12 (n=30) | 43.3 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 16 (n=29) | 41.4 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 20 (n=28) | 57.1 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 24 (n=27) | 40.7 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 28 (n=26) | 69.2 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 32 (n=26) | 57.7 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 36 (n=26) | 61.5 percentage of participants |
| Overall | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Week 40 (n=26) | 46.2 percentage of participants |
Secondary
Psoriasis Area and Severity Index (PASI) Score
Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 7.25 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 6.80 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 4.40 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 3.70 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 3.40 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 4.70 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 7.60 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 14.70 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 3.25 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 4.80 units on a scale |
| Overall | Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 3.80 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 7.50 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 12.80 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 6.20 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 4.40 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 6.60 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 3.95 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 4.70 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 3.25 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 4.50 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 3.40 units on a scale |
| Plaque Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 4.70 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 1.80 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 6.60 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 3.80 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 4.80 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 8.20 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 13.95 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 4.20 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 4.20 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 8.20 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 2.40 units on a scale |
| Psoriatic Arthritis | Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 6.60 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 4.20 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 5.80 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 3.70 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 2.75 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 2.70 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 6.05 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 7.40 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 3.15 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 14.70 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 4.80 units on a scale |
| Pustular Psoriasis | Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 9.90 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 36 (n=44,26,7,6,5) | 3.90 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 32 (n=44,26,7,6,5) | 4.80 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 24 (n=45,27,7,6,5) | 5.60 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 8 (n=50,31,8,6,5) | 14.00 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 20 (n=46,28,7,6,5) | 3.40 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 12 (n=49,30,8,6,5) | 3.40 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 16 (n=48,29,8,6,5) | 9.50 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 28 (n=44,26,7,6,5) | 5.30 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 0 (n=51,31,8,7,5) | 22.20 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 40 (n=43,26,7,5,5) | 3.30 units on a scale |
| Psoriatic Erythroderma | Psoriasis Area and Severity Index (PASI) Score | Week 4 (n=51,31,8,7,5) | 9.20 units on a scale |
Secondary
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
From 0 (best) to 100 (worst)
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 0 (n=8) | 59.5 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 4 (n=8) | 19.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 8 (n=8) | 49.5 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 12 (n=8) | 14.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 16 (n=8) | 41.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 20 (n=7) | 27.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 24 (n=7) | 28.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 28 (n=7) | 17.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 32 (n=7) | 10.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 36 (n=7) | 8.0 mm |
| Overall | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Week 40 (n=7) | 27.0 mm |