A Study of the Safety and Efficacy of Ustekinumab in Adol... | NCT01090427 | Trialant
NCT01090427
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Jan 29, 2015Estimated
Enrollment
110Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Ustekinumab - Half-Standard Dosage
Ustekinumab - Standard Dosage
Placebo
Countries
Belgium
Canada
France
Germany
Hungary
Portugal
Russia
Sweden
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01090427
Obsolete or Duplicate NCT IDs
NCT02166203
Organization Study
CR017053
Secondary IDs
ID
Type
Description
Link
CNTO1275PSO3006
Other Identifier
Janssen Research & Development, LLC
CADMUS
Other Identifier
Janssen Research & Development, LLC
2009-014368-20
EudraCT Number
Brief Title
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jan 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2010
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2014Actual
First Submitted Date
Mar 18, 2010
First Submission Date that Met QC Criteria
Mar 18, 2010
First Posted Date
Mar 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2014
Results First Submitted that Met QC Criteria
Dec 10, 2014
Results First Posted Date
Dec 18, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 24, 2014
Certification/Extension First Submitted that Passed QC Review
Jan 24, 2014
Certification/Extension First Posted Date
Feb 24, 2014Estimated
Last Update Submitted Date
Jan 16, 2015
Last Update Posted Date
Jan 29, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Psoriasis
Keywords
Ustekinumab
Injection
CNTO 1275
Stelara
Pediatric psoriasis
Adolescents
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
110Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ustekinumab Half-standard Dosage
Experimental
Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
Drug: Ustekinumab - Half-Standard Dosage
Other: Placebo
Ustekinumab Standard Dosage
Experimental
Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
Drug: Ustekinumab - Standard Dosage
Other: Placebo
Placebo
Experimental
Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ustekinumab - Half-Standard Dosage
Drug
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
18 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.
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.
Recruitment Details
A total of 110 volunteers from 10 countries were randomized and treated in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (CP)
Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
FG001
Ustekinumab Half-Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
Ustekinumab Standard Dosage
Placebo
Other
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Placebo
Ustekinumab Half-standard Dosage
Ustekinumab Standard Dosage
Week 12
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.
Baseline; Week 12
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.
Week 12
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.
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
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.
Week 12
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.
Week 12
The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.
FG002
Ustekinumab Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
FG004
Placebo -> Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
FG005
Ustekinumab Half-Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
FG006
Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
FG00037 subjects
FG00137 subjects
FG00236 subjects
FG0030 subjects"0" in column indicates this reporting group is not relevant to Control Period.
FG0040 subjects"0" in column indicates this reporting group is not relevant to Control Period.
FG0050 subjects"0" in column indicates this reporting group is not relevant to Control Period.
FG0060 subjects"0" in column indicates this reporting group is not relevant to Control Period.
COMPLETED
FG00037 subjects
FG00137 subjects
FG00236 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
After Controlled Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects"0" in column indicates this reporting group is not relevant to after Control Period.
FG0010 subjects"0" in column indicates this reporting group is not relevant to after Control Period.
FG0020 subjects"0" in column indicates this reporting group is not relevant to after Control Period.
FG00319 subjects
FG00418 subjects
FG00537 subjects
FG00636 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00317 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00037
BG00137
BG00236
BG003110
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00015.6± 1.46
BG00115.1± 1.7
BG00214.8± 1.73
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00119
BG002
Age
Number
participants
Title
Denominators
Categories
12-15 years
Title
Measurements
BG00015
BG00120
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
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.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Units
Counts
Participants
OG00037
OG00137
OG00236
Title
Denominators
Categories
Title
Measurements
OG0005.4
OG00167.6
OG00269.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG002
Cochran-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.
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.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
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.
OG001
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.
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.
Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline; Week 12
ID
Title
Description
OG000
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.
OG001
Ustekinumab Half-Standard Dosage
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.
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.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
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.
OG001
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.
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.
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
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.
OG001
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.
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.
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
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.
OG001
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.
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.
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.
Posted
Mean
Standard Deviation
Scores on a scale
Week 12
ID
Title
Description
OG000
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.
OG001
Secondary
The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
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.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Time Frame
Through Week 60
Description
Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (CP)
Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
0
37
17
37
EG001
Ustekinumab Half-Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
1
37
15
37
EG002
Ustekinumab Standard Dosage (CP)
Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
0
19
15
19
EG004
Placebo -> Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
0
18
13
18
EG005
Ustekinumab Half-Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
5
37
28
37
EG006
Ustekinumab Standard Dosage (After CP)
After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
1
36
23
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG0030 affected19 at risk
EG004
Ear Infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG0030 affected19 at risk
EG004
Monocytosis
Blood and lymphatic system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0022 affected36 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Lip Oedema
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Tooth Deposit
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Tooth Impacted
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Fatigue
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected37 at risk
EG0021 affected36 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pyrexia
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Bacterial Rhinitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Body Tinea
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Herpes Simplex
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Laryngitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG00010 affected37 at risk
EG0015 affected37 at risk
EG0021 affected36 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0013 affected37 at risk
EG0021 affected36 at risk
EG003
Pharyngitis Streptococcal
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Toxoplasmosis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected37 at risk
EG0023 affected36 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Skin Injury
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Haematocrit Decreased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Lymph Node Palpable
Investigations
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Convulsion
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 affected37 at risk
EG0014 affected37 at risk
EG0023 affected36 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0022 affected36 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0021 affected36 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Erythema Multiforme
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0021 affected36 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Point of Contact
Title
Organization
Phone
Extension
Email
VICE PRESIDENT IMMUNOLOGY
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
18 subjects
FG00532 subjects
FG00634 subjects
0 subjects
FG0055 subjects
FG0062 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0062 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
15.2
± 1.65
20
BG00356
Male
BG00020
BG00118
BG00216
BG00354
20
BG00355
16-17 years
Title
Measurements
BG00022
BG00117
BG00216
BG00355
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG002
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.
Units
Counts
Participants
OG00037
OG00137
OG00236
Title
Denominators
Categories
Title
Measurements
OG00010.8
OG00178.4
OG00280.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
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.
OG002
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.
Units
Counts
Participants
OG00032
OG00135
OG00232
Title
Denominators
Categories
Title
Measurements
OG000-1.5± 3.18
OG001-5.6± 6.43
OG002-6.7± 5.63
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] will be used as factors in the model.
0.003
No
Superiority or Other
OG000
OG002
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] will be used as factors in the model.
<0.001
No
Superiority or Other
OG002
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.
Units
Counts
Participants
OG00037
OG00137
OG00236
Title
Denominators
Categories
Title
Measurements
OG0005.4
OG00154.1
OG00261.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG002
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.
Units
Counts
Participants
OG00037
OG00137
OG00236
Title
Denominators
Categories
PGA of 0
Title
Measurements
OG0002.7
OG00132.4
OG00247.2
PGA of 0, 1, or 2
Title
Measurements
OG00032.4
OG00181.1
OG00283.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
PGA of 0
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG002
PGA of 0
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG001
PGA of 0, 1, or 2
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG002
PGA of 0, 1, or 2
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG002
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.
Units
Counts
Participants
OG00037
OG00137
OG00236
Title
Denominators
Categories
PASI 50 responders
Title
Measurements
OG00029.7
OG00181.1
OG00288.9
Participants with PASI score of 0
Title
Measurements
OG0002.7
OG00121.6
OG00238.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
PASI 50 responders
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG002
PASI 50 responders
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
OG000
OG001
Participants with PASI score of 0
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
0.014
No
Superiority or Other
OG000
OG002
Participants with PASI score of 0
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
<0.001
No
Superiority or Other
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.
OG002
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.
Units
Counts
Participants
OG00036
OG00136
OG00236
Title
Denominators
Categories
PedsQL Total scale score
Title
Measurements
OG0003.35± 10.044
OG00110.81± 12.882
OG0028.03± 10.436
PedsQL Psychosocial health summary score
Title
Measurements
OG0003.66± 9.610
OG00112.13± 15.153
OG0028.43± 11.812
PedsQL Physical health summary score
Title
Measurements
OG0002.86± 12.860
OG0018.33± 11.378
OG0027.29± 13.446
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
PedsQL Total Scale Score
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
0.003
No
Superiority or Other
OG000
OG002
PedsQL Total Scale Score
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
0.028
No
Superiority or Other
OG000
OG001
PedsQL Psychosocial health summary score
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
0.005
No
Superiority or Other
OG000
OG002
PedsQL Psychosocial health summary score
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
0.063
No
Superiority or Other
OG000
OG001
PedsQL Physical health summary score
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
0.007
No
Superiority or Other
OG000
OG002
PedsQL Physical health summary score
ANOVA on van der Waerden normal Score
Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
0.020
No
Superiority or Other
Units
Counts
Participants
OG00030
OG00131
OG00230
Title
Denominators
Categories
Title
Measurements
OG00013.3
OG00138.7
OG00256.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
0.027
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).