Psoriasis
Conditions
Keywords
Ustekinumab, Injection, CNTO 1275, Stelara, Pediatric psoriasis, Adolescents
Brief summary
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.
Detailed description
This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study.
Interventions
DRUGUstekinumab - Half-Standard Dosage
Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.
Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
OTHERPlacebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months * Are candidates for phototherapy or systemic treatment of psoriasis * Have screening laboratory test results within the study parameters
Exclusion criteria
* Currently have nonplaque forms of psoriasis * Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab * Received conventional systemic therapies or phototherapy within the last 4 weeks * Received biologic therapies within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Week 12 | The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | Baseline; Week 12 | The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group. |
| The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline. |
| The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | Week 12 | The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group. |
| The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=\>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group. |
| The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | Week 12 | The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life. |
| The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 | Week 12 | — |
| The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (\>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0. |
Countries
Belgium, Canada, France, Germany, Hungary, Portugal, Russia, Sweden, Ukraine, United Kingdom
Participant flow
Recruitment details
A total of 110 volunteers from 10 countries were randomized and treated in this study.
Pre-assignment details
A total of 110 participants started and completed the first period in the study (ie, controlled period \[CP\] and entered the 2nd period (ie, After the Controlled Period \[after CP\]); however, only 101 of the 110 participants completed the 2nd period (after CP) of the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40. | 37 |
| Ustekinumab Half-Standard Dosage Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12. | 37 |
| Ustekinumab Standard Dosage Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12. | 36 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| After Controlled Period | Adverse Event | 0 | 0 | 0 | 2 | 0 | 1 | 0 |
| After Controlled Period | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| After Controlled Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Ustekinumab Standard Dosage | Ustekinumab Half-Standard Dosage | Placebo |
|---|---|---|---|---|
| Age 12-15 years | 55 participants | 20 participants | 20 participants | 15 participants |
| Age 16-17 years | 55 participants | 16 participants | 17 participants | 22 participants |
| Age, Continuous | 15.2 years STANDARD_DEVIATION 1.65 | 14.8 years STANDARD_DEVIATION 1.73 | 15.1 years STANDARD_DEVIATION 1.7 | 15.6 years STANDARD_DEVIATION 1.46 |
| Sex: Female, Male Female | 56 Participants | 20 Participants | 19 Participants | 17 Participants |
| Sex: Female, Male Male | 54 Participants | 16 Participants | 18 Participants | 20 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 37 | 15 / 37 | 13 / 36 | 15 / 19 | 13 / 18 | 28 / 37 | 23 / 36 |
| serious Total, serious adverse events | 0 / 37 | 1 / 37 | 0 / 36 | 0 / 19 | 0 / 18 | 5 / 37 | 1 / 36 |
Outcome results
Primary
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
Time frame: Week 12
Population: The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 5.4 Percentage of Participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 67.6 Percentage of Participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 69.4 Percentage of Participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.
Time frame: Baseline; Week 12
Population: Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | -1.5 Scores on a scale | Standard Deviation 3.18 |
| Ustekinumab Half-Standard Dosage | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | -5.6 Scores on a scale | Standard Deviation 6.43 |
| Ustekinumab Standard Dosage | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | -6.7 Scores on a scale | Standard Deviation 5.63 |
p-value: 0.003ANOVA on van der Waerden normal Score
p-value: <0.001ANOVA on van der Waerden normal Score
Secondary
The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.
Time frame: Week 12
Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Psychosocial health summary score | 3.66 Scores on a scale | Standard Deviation 9.61 |
| Placebo | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Total scale score | 3.35 Scores on a scale | Standard Deviation 10.044 |
| Placebo | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Physical health summary score | 2.86 Scores on a scale | Standard Deviation 12.86 |
| Ustekinumab Half-Standard Dosage | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Psychosocial health summary score | 12.13 Scores on a scale | Standard Deviation 15.153 |
| Ustekinumab Half-Standard Dosage | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Total scale score | 10.81 Scores on a scale | Standard Deviation 12.882 |
| Ustekinumab Half-Standard Dosage | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Physical health summary score | 8.33 Scores on a scale | Standard Deviation 11.378 |
| Ustekinumab Standard Dosage | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Total scale score | 8.03 Scores on a scale | Standard Deviation 10.436 |
| Ustekinumab Standard Dosage | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Physical health summary score | 7.29 Scores on a scale | Standard Deviation 13.446 |
| Ustekinumab Standard Dosage | The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 | PedsQL Psychosocial health summary score | 8.43 Scores on a scale | Standard Deviation 11.812 |
Comparison: PedsQL Total Scale Scorep-value: 0.003ANOVA on van der Waerden normal Score
Comparison: PedsQL Total Scale Scorep-value: 0.028ANOVA on van der Waerden normal Score
Comparison: PedsQL Psychosocial health summary scorep-value: 0.005ANOVA on van der Waerden normal Score
Comparison: PedsQL Psychosocial health summary scorep-value: 0.063ANOVA on van der Waerden normal Score
Comparison: PedsQL Physical health summary scorep-value: 0.007ANOVA on van der Waerden normal Score
Comparison: PedsQL Physical health summary scorep-value: 0.02ANOVA on van der Waerden normal Score
Secondary
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.
Time frame: Week 12
Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | PGA of 0 | 2.7 Percentage of participants |
| Placebo | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | PGA of 0, 1, or 2 | 32.4 Percentage of participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | PGA of 0 | 32.4 Percentage of participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | PGA of 0, 1, or 2 | 81.1 Percentage of participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | PGA of 0 | 47.2 Percentage of participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 | PGA of 0, 1, or 2 | 83.3 Percentage of participants |
Comparison: PGA of 0p-value: <0.001Cochran-Mantel-Haenszel
Comparison: PGA of 0p-value: <0.001Cochran-Mantel-Haenszel
Comparison: PGA of 0, 1, or 2p-value: <0.001Cochran-Mantel-Haenszel
Comparison: PGA of 0, 1, or 2p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=\>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.
Time frame: Week 12
Population: The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | 10.8 Percentage of Participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | 78.4 Percentage of Participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | 80.6 Percentage of Participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.
Time frame: Week 12
Population: The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | 5.4 Percentage of Participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | 54.1 Percentage of Participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups | 61.1 Percentage of Participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (\>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.
Time frame: Week 12
Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | PASI 50 responders | 29.7 Percentage of participants |
| Placebo | The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | Participants with PASI score of 0 | 2.7 Percentage of participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | PASI 50 responders | 81.1 Percentage of participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | Participants with PASI score of 0 | 21.6 Percentage of participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | PASI 50 responders | 88.9 Percentage of participants |
| Ustekinumab Standard Dosage | The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 | Participants with PASI score of 0 | 38.9 Percentage of participants |
Comparison: PASI 50 respondersp-value: <0.001Cochran-Mantel-Haenszel
Comparison: PASI 50 respondersp-value: <0.001Cochran-Mantel-Haenszel
Comparison: Participants with PASI score of 0p-value: 0.014Cochran-Mantel-Haenszel
Comparison: Participants with PASI score of 0p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
Time frame: Week 12
Population: Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 | 13.3 Percentage of participants |
| Ustekinumab Half-Standard Dosage | The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 | 38.7 Percentage of participants |
| Ustekinumab Standard Dosage | The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 | 56.7 Percentage of participants |
p-value: 0.027Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel