A Study to Evaluate the Efficacy, Safety, and Pharmacokin... | NCT03451851 | Trialant
NCT03451851
Sponsor
Janssen Research & Development, LLC
Status
Active, not recruiting
Last Update Posted
Jul 6, 2026Actual
Enrollment
120Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Guselkumab
Placebo for guselkumab
Etanercept
Countries
United States
Australia
Belgium
Canada
Germany
Hungary
Italy
Netherlands
Poland
Protocol Section
Identification Module
NCT ID
NCT03451851
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108452
Secondary IDs
ID
Type
Description
Link
CNTO1959PSO3011
Other Identifier
Janssen Research & Development, LLC
2023-503378-19-00
Registry Identifier
EUCT number
Brief Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Official Title
A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)
Acronym
PROTOSTAR
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jul 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 11, 2018Actual
Primary Completion Date
Jul 19, 2023Actual
Completion Date
Dec 18, 2026Estimated
First Submitted Date
Feb 26, 2018
First Submission Date that Met QC Criteria
Feb 26, 2018
First Posted Date
Mar 2, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jan 29, 2025
Results First Submitted that Met QC Criteria
Mar 27, 2025
Results First Posted Date
Mar 28, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 16, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Mar 28, 2025Actual
Last Update Submitted Date
Jul 2, 2026
Last Update Posted Date
Jul 6, 2026Actual
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
Yes
Is FDA Regulated Device
No
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
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
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
120Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Group 1: Guselkumab
Experimental
Participants in Part 1a (age greater than or equal to (>=) 12 - less than (<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose >=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
Drug: Guselkumab
Drug: Placebo for guselkumab
Part 1 Group 2: Placebo for Guselkumab
Placebo Comparator
Participants in Part 1a (age >= 12 - <18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose >=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
Drug: Guselkumab
Drug: Placebo for guselkumab
Part 1 Group 3: Etanercept
Active Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Guselkumab
Drug
Participants will receive a weight-based dose of guselkumab subcutaneously.
Part 1 Group 1: Guselkumab
Part 1 Group 2: Placebo for Guselkumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
At Week 16
Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.
At Week 16
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis [PsA]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (>=) 3, Psoriasis Area and Severity Index (PASI) >=12, >=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI>=20, >20% BSA involvement, or IGA=4
Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment)
Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy
Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling
Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention
Exclusion Criteria:
Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Has previously received guselkumab or etanercept
Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Years
Maximum Age
17 Years
Standard Ages
Child
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
Crauwels H, Ringold S, Howard S, Van Hartingsveldt B, Smith V, Jett M, Baguet T, Adamson E, Chakravarty SD, Leu JH. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data. Paediatr Drugs. 2026 Jan;28(1):69-81. doi: 10.1007/s40272-025-00725-2. Epub 2025 Oct 28.
This result is currently reported for primary analysis till clinical cut-off date 29-Mar-2024. In Part 1, the enrollment of participants aged greater than or equal to (>=) 6 to less than (<) 12 years started only after all participants aged >=12 to <18 years of age had finished Week 16 of the study. Long-term extension (LTE) phase is still ongoing, and results will be posted upon study completion.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Participants in Part 1a (age >= 12 - <18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.
Drug: Guselkumab
Drug: Etanercept
Part 2: Guselkumab
Experimental
Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter.
Drug: Guselkumab
Part 1 Group 3: Etanercept
Part 2: Guselkumab
CNTO1959
Placebo for guselkumab
Drug
Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
Part 1 Group 1: Guselkumab
Part 1 Group 2: Placebo for Guselkumab
Etanercept
Drug
Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
Part 1 Group 3: Etanercept
Enbrel
At Week 16
Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
At Week 16
Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.
At Week 16
Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score.
Baseline and Week 16
Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment
PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.
At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.
At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of >=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.
Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.
Week 20, 24, 28, 32, 36, 40, 44, 48, and 52
Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.
At Week 16
Part 1: Percent Improvement From Baseline in PASI Through Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
Weeks 4, 8, 12, and 16
Part 2: Percent Improvement From Baseline in PASI Through Week 52
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
Weeks 4, 8, 12, and 16
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Weeks 4, 8, 12, and 16
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
Part 2: Change From Baseline in CDLQI Score Through Week 52
Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Baseline, Weeks 8, 16, 28, 36, and 52
Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
At Week 16
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
Weeks 8, 16, 28, 36, and 52
Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1
The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.
At Week 16
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.
Weeks 8, 16, 28, 36, and 52
Part 1: Change From Baseline in FDLQI Score at Week 16
The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.
Baseline and Week 16
Part 2: Change From Baseline in FDLQI Score Through Week 52
The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.
Baseline, Weeks 8, 16, 28, 36, and 52
Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16
Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Baseline and Week 16
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time
From Week 52 to End of the study (EOS) (December 2026)
LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time
From Week 52 to EOS (December 2026)
LTE Phase: Percent Improvement From Baseline in PASI Over Time
From Week 52 to EOS (December 2026)
LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time
From Week 52 to EOS (Dec 2026)
LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52
Week 60 and Week 84
LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment
Week 60 and Week 84
LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52
Week 60 and Week 84
LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52
Week 60 and Week 84
San Diego
California
92123
United States
Dermatologic Surgery Specialists
Macon
Georgia
31217
United States
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Chicago
Illinois
60611
United States
Arlington Dermatology
Rolling Meadows
Illinois
60008
United States
Windsor Dermatology
East Windsor
New Jersey
08520-2505
United States
Mt. Sinai School of Medicine
New York
New York
10003
United States
Wright State Physicians Health Center
Dayton
Ohio
45324
United States
Arlington Center for Dermatology
Arlington
Texas
76011-3800
United States
Dell Children's Medical Center of Central Texas
Austin
Texas
78723
United States
Eastern Health Research
Box Hill
3128
Australia
Royal North Shore Hospital
St Leonards
2065
Australia
Veracity Clinical Research
Woolloongabba
4102
Australia
Cliniques Universitaires Saint Luc
Brussels
1200
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège
4000
Belgium
Kirk Barber Reseach Inc.
Calgary
Alberta
T2G 1B1
Canada
Dermatology Research Institute Inc
Calgary
Alberta
T2J 7E1
Canada
Skin Care Centre
Vancouver
British Columbia
V5Z 4E8
Canada
Universitatsklinikum Bonn
Bonn
53127
Germany
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden
01307
Germany
Universitatsklinikum Frankfurt
Frankfurt
60590
Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel
24105
Germany
Praxis Dr. med. Beate Schwarz - Germany
Langenau
89129
Germany
Company for Medical Study & Service Selters
Selters
56242
Germany
Hautarztpraxis Dr. Leitz & Kollegen
Stuttgart
70178
Germany
Obudai Egeszsegugyi Centrum Kft
Budapest
1036
Hungary
Debreceni Egyetem
Debrecen
4032
Hungary
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc
3526
Hungary
Szegedi Tudomanyegyetem
Szeged
6720
Hungary
Ospedali Riuniti Di Ancona
Ancona
60026
Italy
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna
40138
Italy
AOU di Cagliari
Cagliari
09124
Italy
Azienda Ospedaliera di Padova
Padova
35128
Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia
42123
Italy
Radboud University Medical Center
Nijmegen
6525 GA
Netherlands
Dermed Centrum Medyczne Sp z o o
Lodz
90-265
Poland
Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
Warsaw
03-924
Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw
50 556
Poland
Derived
Prajapati VH, Seyger MMB, Wilsmann-Theis D, Szakos E, Kaszuba A, van Hartingsveldt B, Jett M, Jiang G, Li S, Sinha V, Crauwels H, DeKlotz CMC, Paller AS. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Br J Dermatol. 2025 Mar 18;192(4):618-628. doi: 10.1093/bjd/ljae502.
FG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
FG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
FG003
Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
FG004
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
FG005
Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
FG006
Part 2: Guselkumab (Week 0-16)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and 16.
FG007
Part 2: Guselkumab (Week 16-52)
Participants who completed Week 16 during PCP continued to receive weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection q8w from Weeks 16 through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
FG00025 subjects
FG00141 subjects
FG00226 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00628 subjects
FG0070 subjects
COMPLETED
FG00024 subjects
FG00141 subjects
FG00223 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00627 subjects
FG0070 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Parent/Guardian
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal and Retreament: Week 16-52
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00323 subjectsOnly eligible participants who crossed over to receive Guselkumab included in this period.
FG00441 subjects
FG00522 subjectsOnly eligible participants who crossed over to receive Guselkumab included in this period.
FG0060 subjects
FG00727 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00323 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other Withdrawal by Parent/Guardian
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
BG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
BG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
BG003
Part 2: Guselkumab (Week 0-16)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and 16.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00141
BG00226
BG00328
BG004120
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
>=6 to <12 years
Title
Measurements
BG00010
BG00110
BG00210
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00117
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
AUSTRALIA
Title
Measurements
BG0000
BG0011
BG002
AgeContinuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00012.4± 3.63
BG00113.4± 2.86
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
Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
The efficacy analysis for Part 1 of the study was based upon the full analysis set (FAS) which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentages of participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG00016.0
OG00165.9
OG00269.2
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
<0.001
Difference in percentage
49.9
2-Sided
95
25.9
69.4
Superiority
Primary
Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentage of Participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentage of Participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentages of participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentages of participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment
PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.
Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
Percentages of participants
At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
ID
Title
Description
OG000
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Secondary
Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.
Analysis population included guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
Posted
Number
At 4 and 8 weeks post retreatment
At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
ID
Title
Description
OG000
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Secondary
Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
Posted
Number
Percentages of participants
At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
ID
Title
Description
OG000
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Secondary
Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of >=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.
Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
Posted
Number
Percentage of Participants
Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Secondary
Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.
Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for "Group 2 (Part 1): Guselkumab (Week 16-52)" arm only.
Posted
Number
Percentage of participants
Week 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Secondary
Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentages of participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 1: Percent Improvement From Baseline in PASI Through Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, n (number analyzed): number of participants evaluable for each arm at specified time points.
Posted
Mean
Standard Deviation
Percent improvement
Weeks 4, 8, 12, and 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
OG001
Secondary
Part 2: Percent Improvement From Baseline in PASI Through Week 52
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Percent improvement
Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Counts
Secondary
Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentages of participants
Weeks 4, 8, 12, and 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
FAS for Part 2 included all participants enrolled in Part 2.
Posted
Number
Percentages of participants
Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Secondary
Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Number
Percentages of participants
Weeks 4, 8, 12, and 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
FAS for Part 2 included all participants enrolled in Part 2.
Posted
Number
Percentages of participants
Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Secondary
Part 2: Change From Baseline in CDLQI Score Through Week 52
Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 8, 16, 28, 36, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Counts
Participants
Secondary
Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
Posted
Number
Percentages of participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Secondary
Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.
FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
Posted
Number
Percentages of participants
Weeks 8, 16, 28, 36, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Counts
Participants
Secondary
Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1
The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
Posted
Number
Percentages of participants
At Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.
FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
Posted
Number
Percentages of participants
Weeks 8, 16, 28, 36, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Counts
Secondary
Part 1: Change From Baseline in FDLQI Score at Week 16
The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
OG001
Secondary
Part 2: Change From Baseline in FDLQI Score Through Week 52
The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.
FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Mean
Standard Deviation
Score on scale
Baseline, Weeks 8, 16, 28, 36, and 52
ID
Title
Description
OG000
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Counts
Secondary
Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16
Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Secondary
Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Units
Counts
Participants
Secondary
LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time
Not Posted
Dec 2027
From Week 52 to End of the study (EOS) (December 2026)
Participants
Secondary
LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time
Not Posted
Dec 2027
From Week 52 to EOS (December 2026)
Participants
Secondary
LTE Phase: Percent Improvement From Baseline in PASI Over Time
Not Posted
Dec 2027
From Week 52 to EOS (December 2026)
Participants
Secondary
LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time
Not Posted
Dec 2027
From Week 52 to EOS (Dec 2026)
Participants
Secondary
LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52
Not Posted
Dec 2027
Week 60 and Week 84
Participants
Secondary
LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment
Not Posted
Dec 2027
Week 60 and Week 84
Participants
Secondary
LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52
Not Posted
Dec 2027
Week 60 and Week 84
Participants
Secondary
LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52
Not Posted
Dec 2027
Week 60 and Week 84
Participants
Time Frame
PCP (Part 1): Week 0 to 16; Withdrawal and re-treatment period (Part 1): Week 16 to 52; Part 2: Week 0 to 52
Description
Safety analysis set included all treated participants who received at least 1 injection of study agent (partial or complete). As planned, data for Part 2 has been reported collectively from Week 0 to 52 since participants continued the same treatment through Week 52.
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
PCP-Group 1 (Part 1): Placebo (Week 0-16)
Adolescent participants (aged >=12 to <18 years) received placebo matched to guselkumab as subcutaneous (SC) injection at Weeks 0, 4, and 12 during the placebo-controlled period (PCP). Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years were enrolled and began receiving the same dose regimen starting from Week 0 until Week 16.
0
25
0
25
17
25
EG001
PCP-Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
0
41
1
41
17
41
EG002
PCP-Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
0
26
0
26
15
26
EG003
Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
0
23
1
23
16
23
EG004
Withdrawal and Re-treatment Period-Group 2 (Part 1): Guselkumab (Week 16-52)
Participants who received guselkumab during PCP were assessed for PASI response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 16, 20 and then q8w thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost >= 50 % of their Week 16 PASI response, at which time they were retreated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab every 8 weeks thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
0
41
0
41
29
41
EG005
Withdrawal and Re-treatment Period- Group 3 (Part 1): Etanercept to Guselkumab (Week 16-52)
Participants who received etanercept during the PCP had the option to continue in the study or to discontinue the study. Participants that continued received weight-based doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 20 and 24, followed by q8w dosing through Week 48 and remaining participants discontinued from the study. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
0
22
0
22
13
22
EG006
Part 2: Guselkumab (Week 0-52)
Adolescent participants received weight-based dose of open-label guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) as SC injection at Weeks 0, 4, and q8w thereafter through Week 52. All participants who completed Part 2 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
0
28
1
28
23
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chronic Tonsillitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG0031 affected23 at risk
EG004
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG0030 affected23 at risk
EG0040 affected41 at risk
EG0050 affected22 at risk
EG0061 affected28 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Myopia
Eye disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected41 at risk
EG0020 affected26 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Application Site Haematoma
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Fatigue
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0022 affected26 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Injection Site Erythema
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Injection Site Haematoma
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Injection Site Induration
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Injection Site Swelling
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Abscess
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0021 affected26 at risk
EG003
Bacterial Vulvovaginitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0022 affected26 at risk
EG003
Chronic Tonsillitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Ear Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Enterobiasis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Gastrointestinal Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Helminthic Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Lice Infestation
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Molluscum Contagiosum
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0007 affected25 at risk
EG0015 affected41 at risk
EG0023 affected26 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Otitis Media
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0021 affected26 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Tinea Capitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Tinea Versicolour
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0002 affected25 at risk
EG0014 affected41 at risk
EG0022 affected26 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Viral Diarrhoea
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0021 affected26 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Peroneal Nerve Injury
Injury, poisoning and procedural complications
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Blood Pressure Decreased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Cardiac Murmur
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Liver Function Test Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
White Blood Cell Count Increased
Investigations
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0022 affected26 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Ligament Laxity
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Musculoskeletal Discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0013 affected41 at risk
EG0021 affected26 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0021 affected26 at risk
EG003
Attention Deficit Hyperactivity Disorder
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Tonsillar Hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected41 at risk
EG0020 affected26 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Diffuse Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Lichen Planus
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Skin Hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 26.1
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected41 at risk
EG0020 affected26 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
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00175.6
OG00269.2
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
<0.001
Difference in percentage
55.6
2-Sided
95
32.1
74.0
Superiority
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG00016.0
OG00156.1
OG00253.8
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
=0.003
Difference in percentage
40.1
2-Sided
95
15.6
61.3
Superiority
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG0004.0
OG00139.0
OG00226.9
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
=0.004
Difference in percentage
35
2-Sided
95
10.5
56.8
Superiority
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG0000
OG00134.1
OG00226.9
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
=0.002
Difference in percentage
34.1
2-Sided
25
9.7
56.1
Superiority
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG000-1.68± 6.323
OG001-7.12± 7.633
OG002-6.08± 5.692
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
Guselkumab Vs Placebo
Mixed model repeated measures (MMRM)
<0.001
LS Mean difference
-5.4
2-Sided
95
-7.33
-3.06
Superiority
Units
Counts
Participants
OG0004
Title
Denominators
Categories
4 weeks after retreatment of guselkumab
ParticipantsOG0004
Title
Measurements
OG0000
8 weeks after retreatment of guselkumab
ParticipantsOG0002
Title
Measurements
OG00050.0
Units
Counts
Participants
OG0004
Title
Denominators
Categories
4 weeks after retreatment: >=50% improvement
ParticipantsOG0004
Title
Measurements
OG00050.0
4 weeks after retreatment: >=75% improvement
ParticipantsOG0004
Title
Measurements
OG0000
4 weeks after retreatment:>= 90% improvement
ParticipantsOG0004
Title
Measurements
OG0000
4 weeks after retreatment: 100% improvement
ParticipantsOG0004
Title
Measurements
OG0000
8 weeks after retreatment: >=50% improvement
ParticipantsOG0002
Title
Measurements
OG00050.0
8 weeks after retreatment: >=75% improvement
ParticipantsOG0002
Title
Measurements
OG00050.0
8 weeks after retreatment:>= 90% improvement
ParticipantsOG0002
Title
Measurements
OG00050.0
8 weeks after retreatment: 100% improvement
ParticipantsOG0002
Title
Measurements
OG00050.0
Units
Counts
Participants
OG0004
Title
Denominators
Categories
4 Weeks after retreatment: IGA-0
ParticipantsOG0004
Title
Measurements
OG0000
4 Weeks after retreatment: IGA-0 or 1
ParticipantsOG0004
Title
Measurements
OG00025.0
4 Weeks after retreatment: IGA-2
ParticipantsOG0004
Title
Measurements
OG00075.0
8 Weeks after retreatment: IGA-0
ParticipantsOG0002
Title
Measurements
OG00050.0
8 Weeks after retreatment: IGA-0 or 1
ParticipantsOG0002
Title
Measurements
OG00050.0
8 Weeks after retreatment: IGA- 2
ParticipantsOG0002
Title
Measurements
OG000100.0
Units
Counts
Participants
OG00023
Title
Denominators
Categories
Week 20
Title
Measurements
OG0000
Week 24
Title
Measurements
OG0000
Week 28
Title
Measurements
OG0000
Week 32
Title
Measurements
OG0000
Week 36
Title
Measurements
OG0000
Week 40
Title
Measurements
OG0000
Week 44
Title
Measurements
OG0009.3
Week 48
Title
Measurements
OG00019.1
Week 52
Title
Measurements
OG00019.1
Units
Counts
Participants
OG00023
Title
Denominators
Categories
Week 20
Title
Measurements
OG000100
Week 24
Title
Measurements
OG000100
Week 28
Title
Measurements
OG00086.7
Week 32
Title
Measurements
OG00077.5
Week 36
Title
Measurements
OG00063.9
Week 40
Title
Measurements
OG00050.2
Week 44
Title
Measurements
OG00035.8
Week 48
Title
Measurements
OG00030.7
Week 52
Title
Measurements
OG00025.6
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Title
Measurements
OG00028.0
OG00187.8
OG00276.9
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
<0.001
p-value is nominal
Difference in percentage
59.8
2-Sided
95
36.9
77.6
Superiority
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Week 4
ParticipantsOG00025
ParticipantsOG00141
ParticipantsOG00225
Title
Measurements
OG00013.37± 30.074
OG00139.12± 27.907
OG00242.53± 26.013
Week 8
ParticipantsOG00024
ParticipantsOG00139
ParticipantsOG00226
Title
Measurements
OG000
Week 12
ParticipantsOG00025
ParticipantsOG00141
ParticipantsOG00224
Title
Measurements
OG000
Week 16
ParticipantsOG00025
ParticipantsOG00141
ParticipantsOG00224
Title
Measurements
OG000
Participants
OG00028
Title
Denominators
Categories
Week 4
ParticipantsOG00028
Title
Measurements
OG00048.33± 26.781
Week 8
ParticipantsOG00028
Title
Measurements
OG00079.05± 21.177
Week 12
ParticipantsOG00027
Title
Measurements
OG00086.40± 15.541
Week 16
ParticipantsOG00026
Title
Measurements
OG00091.96± 11.177
Week 20
ParticipantsOG00027
Title
Measurements
OG00091.10± 14.851
Week 28
ParticipantsOG00027
Title
Measurements
OG00093.44± 12.948
Week 36
ParticipantsOG00027
Title
Measurements
OG00095.77± 7.848
Week 44
ParticipantsOG00027
Title
Measurements
OG00095.95± 7.430
Week 52
ParticipantsOG00027
Title
Measurements
OG00096.32± 7.478
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Week 4: >= 50% improvement
Title
Measurements
OG0008.0
OG00134.1
OG00238.5
Week 4: >= 75% improvement
Title
Measurements
OG0008.0
OG00112.2
OG00215.4
Week 4: >= 90% improvement
Title
Measurements
OG0004.0
OG0012.4
OG0023.8
Week 4: 100% improvement
Title
Measurements
OG0000
OG0010
OG0020
Week 8: >= 50% improvement
Title
Measurements
OG00020.0
OG00178.0
OG00273.1
Week 8: >= 75% improvement
Title
Measurements
OG0008.0
OG00151.2
OG00246.2
Week 8: >= 90% improvement
Title
Measurements
OG0004.0
OG00134.1
OG00219.2
Week 8: 100% improvement
Title
Measurements
OG0004.0
OG00112.2
OG00211.5
Week 12: >= 50% improvement
Title
Measurements
OG00024.0
OG00185.4
OG00276.9
Week 12: >= 75% improvement
Title
Measurements
OG00012.0
OG00173.2
OG00261.5
Week 12: >= 90% improvement
Title
Measurements
OG0008.0
OG00156.1
OG00238.5
Week 12: 100% improvement
Title
Measurements
OG0000
OG00134.1
OG00226.9
Week 16: >= 50% improvement
Title
Measurements
OG00028.0
OG00187.8
OG00276.9
Week 16: >= 75% improvement
Title
Measurements
OG00020.0
OG00175.6
OG00269.2
Week 16: >= 90% improvement
Title
Measurements
OG00016.0
OG00156.1
OG00253.8
Week 16: 100% improvement
Title
Measurements
OG0000
OG00134.1
OG00226.9
Counts
Participants
OG00028
Title
Denominators
Categories
Week 4: >= 50% improvement
Title
Measurements
OG00042.9
Week 4: >= 75% improvement
Title
Measurements
OG00014.3
Week 4: >= 90% improvement
Title
Measurements
OG00014.3
Week 4: 100% improvement
Title
Measurements
OG0003.6
Week 8: >= 50% improvement
Title
Measurements
OG00089.3
Week 8: >= 75% improvement
Title
Measurements
OG00067.9
Week 8: >= 90% improvement
Title
Measurements
OG00039.3
Week 8: 100% improvement
Title
Measurements
OG00017.9
Week 12: >= 50% improvement
Title
Measurements
OG00096.4
Week 12: >= 75% improvement
Title
Measurements
OG00075.0
Week 12: >= 90% improvement
Title
Measurements
OG00042.9
Week 12: 100% improvement
Title
Measurements
OG00025.0
Week 16: >= 50% improvement
Title
Measurements
OG00092.9
Week 16: >= 75% improvement
Title
Measurements
OG00082.1
Week 16: >= 90% improvement
Title
Measurements
OG00064.3
Week 16: 100% improvement
Title
Measurements
OG00035.7
Week 20: >= 50% improvement
Title
Measurements
OG00092.9
Week 20: >= 75% improvement
Title
Measurements
OG00082.1
Week 20: >= 90% improvement
Title
Measurements
OG00075.0
Week 20: 100% improvement
Title
Measurements
OG00039.3
Week 28: >= 50% improvement
Title
Measurements
OG00092.9
Week 28: >= 75% improvement
Title
Measurements
OG00089.3
Week 28: >= 90% improvement
Title
Measurements
OG00075.0
Week 28: 100% improvement
Title
Measurements
OG00046.4
Week 36: >= 50% improvement
Title
Measurements
OG00096.4
Week 36: >= 75% improvement
Title
Measurements
OG00089.3
Week 36: >= 90% improvement
Title
Measurements
OG00082.1
Week 36: 100% improvement
Title
Measurements
OG00053.6
Week 44: >= 50% improvement
Title
Measurements
OG00096.4
Week 44: >= 75% improvement
Title
Measurements
OG00089.3
Week 44: >= 90% improvement
Title
Measurements
OG00082.1
Week 44: 100% improvement
Title
Measurements
OG00053.6
Week 52: >= 50% improvement
Title
Measurements
OG00096.4
Week 52: >= 75% improvement
Title
Measurements
OG00092.9
Week 52: >= 90% improvement
Title
Measurements
OG00082.1
Week 52: 100% improvement
Title
Measurements
OG00053.6
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00025
OG00141
OG00226
Title
Denominators
Categories
Week 4 : IGA of cleared (0)
Title
Measurements
OG0000
OG0010
OG0020
Week 4 : IGA of cleared (0) or minimal (1)
Title
Measurements
OG0008.0
OG00119.5
OG00223.1
Week 4 :IGA of mild or better (<=2)
Title
Measurements
OG00020.0
OG00163.4
OG00273.1
Week 8: IGA of cleared (0)
Title
Measurements
OG0004.0
OG00122.0
OG00211.5
Week 8 : IGA of cleared (0) or minimal (1)
Title
Measurements
OG0008.0
OG00158.5
OG00250.0
Week 8 :IGA of mild or better (<=2)
Title
Measurements
OG00024.0
OG00178.0
OG00288.5
Week 12: IGA of cleared (0)
Title
Measurements
OG0004.0
OG00143.9
OG00226.9
Week 12 : IGA of cleared (0) or minimal (1)
Title
Measurements
OG0008.0
OG00170.7
OG00265.4
Week 12 :IGA of mild or better (<=2)
Title
Measurements
OG00040.0
OG00187.8
OG00284.6
Week 16: IGA of cleared (0)
Title
Measurements
OG0004.0
OG00139.0
OG00226.9
Week 16 : IGA of cleared (0) or minimal (1)
Title
Measurements
OG00016.0
OG00165.9
OG00269.2
Week 16 :IGA of mild or better (<=2)
Title
Measurements
OG00048.0
OG00192.7
OG00284.6
Units
Counts
Participants
OG00028
Title
Denominators
Categories
Week 4: IGA of cleared (0)
Title
Measurements
OG0003.6
Week 4: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00025.0
Week 4:IGA of mild or better (<=2)
Title
Measurements
OG00057.1
Week 8: IGA of cleared (0)
Title
Measurements
OG00025.0
Week 8: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00064.3
Week 8:IGA of mild or better (<=2)
Title
Measurements
OG00092.9
Week 12: IGA of cleared (0)
Title
Measurements
OG00035.7
Week 12: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00075.0
Week 12:IGA of mild or better (<=2)
Title
Measurements
OG00096.4
Week 16: IGA of cleared (0)
Title
Measurements
OG00046.4
Week 16: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00089.3
Week 16:IGA of mild or better (<=2)
Title
Measurements
OG00092.9
Week 20: IGA of cleared (0)
Title
Measurements
OG00050.0
Week 20: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00082.1
Week 20:IGA of mild or better (<=2)
Title
Measurements
OG00096.4
Week 28: IGA of cleared (0)
Title
Measurements
OG00057.1
Week 28: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00078.6
Week 28:IGA of mild or better (<=2)
Title
Measurements
OG00096.4
Week 36: IGA of cleared (0)
Title
Measurements
OG00064.3
Week 36: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00089.3
Week 36:IGA of mild or better (<=2)
Title
Measurements
OG00089.3
Week 44: IGA of cleared (0)
Title
Measurements
OG00064.3
Week 44: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00085.7
Week 44: IGA of mild or better (<=2)
Title
Measurements
OG00089.3
Week 52: IGA of cleared (0)
Title
Measurements
OG00075.0
Week 52: IGA of cleared (0) or minimal (1)
Title
Measurements
OG00085.7
Week 52: IGA of mild or better (<=2)
Title
Measurements
OG00092.9
OG00028
Title
Denominators
Categories
Week 8
ParticipantsOG00028
Title
Measurements
OG000-5.6± 6.40
Week 16
ParticipantsOG00026
Title
Measurements
OG000-6.8± 6.32
Week 28
ParticipantsOG00027
Title
Measurements
OG000-6.7± 6.54
Week 36
ParticipantsOG00027
Title
Measurements
OG000-7.0± 6.88
Week 52
ParticipantsOG00026
Title
Measurements
OG000-7.3± 6.83
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00023
OG00139
OG00226
Title
Denominators
Categories
Title
Measurements
OG00017.4
OG00164.1
OG00238.5
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
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
=0.002
p-value is nominal
Difference in percentage
46.7
2-Sided
95
21.9
67.3
Superiority
OG00024
Title
Denominators
Categories
Week 8
Title
Measurements
OG00050.0
Week 16
Title
Measurements
OG00058.3
Week 28
Title
Measurements
OG00066.7
Week 36
Title
Measurements
OG00062.5
Week 52
Title
Measurements
OG00066.7
OG001
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00023
OG00136
OG00226
Title
Denominators
Categories
Title
Measurements
OG00013.0
OG00136.1
OG00224.0
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
Guselkumab Vs Placebo
Fisher Exact
P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).
=0.139
p-value is nominal
Difference in Percentage
23.1
2-Sided
95
-3.4
47.0
Superiority
Participants
OG00022
Title
Denominators
Categories
Week 8
Title
Measurements
OG00027.3
Week 16
Title
Measurements
OG00031.8
Week 28
Title
Measurements
OG00059.1
Week 36
Title
Measurements
OG00036.4
Week 52
Title
Measurements
OG00050.0
Group 2 (Part 1): Guselkumab (Week 0-16)
Adolescent participants received weight-adjusted doses of guselkumab (1.3 mg/kg for body weight [BW] <70 kg, 100 mg for BW >=70 kg) via subcutaneous injection at Weeks 0, 4, and 12 during PCP. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.
Units
Counts
Participants
OG00024
OG00141
OG00223
Title
Denominators
Categories
Title
Measurements
OG000-0.50± 6.984
OG001-6.22± 6.299
OG002-6.22± 4.814
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
Guselkumab Vs Placebo
MMRM model
<0.001
p-value is nominal
Difference in LS Mean
-5.44
2-Sided
95
-8.00
-2.87
Superiority
Participants
OG00027
Title
Denominators
Categories
Week 8
ParticipantsOG00027
Title
Measurements
OG000-5.4± 5.58
Week 16
ParticipantsOG00025
Title
Measurements
OG000-5.5± 5.90
Week 28
ParticipantsOG00027
Title
Measurements
OG000-7.5± 6.15
Week 36
ParticipantsOG00026
Title
Measurements
OG000-6.7± 5.00
Week 52
ParticipantsOG00026
Title
Measurements
OG000-7.8± 5.68
OG002
Group 3 (Part 1): Etanercept (Week 0-16)
Adolescent participants received weight-based dose of open-label etanercept 0.8 mg/kg for BW <63 kg and 50 mg for BW >=63 kg SC injection once weekly from Week 0 to Week 15. Once adolescent participants completed Week 16, eligible participants aged >=6 to <12 years began receiving the same dose regimen starting from Week 0 until Week 16.