An Efficacy and Safety of CNTO 1959 (Guselkumab) in Parti... | NCT02325219 | Trialant
NCT02325219
Sponsor
Janssen Pharmaceutical K.K.
Status
Completed
Last Update Posted
May 22, 2020Actual
Enrollment
192Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
CNTO 1959 50 mg
CTNO 1959 100 mg
Placebo 50 mg
Placebo 100 mg
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02325219
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR103833
Secondary IDs
ID
Type
Description
Link
CNTO1959PSO3004
Other Identifier
Janssen Pharmaceutical K.K., Japan
Brief Title
An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Acronym
Not provided
Organization
Janssen Pharmaceutical K.K.INDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 19, 2014Actual
Primary Completion Date
Mar 2, 2016Actual
Completion Date
Feb 8, 2019Actual
First Submitted Date
Dec 19, 2014
First Submission Date that Met QC Criteria
Dec 19, 2014
First Posted Date
Dec 24, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 30, 2020
Results First Submitted that Met QC Criteria
Apr 30, 2020
Results First Posted Date
May 14, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 20, 2020
Last Update Posted Date
May 22, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Pharmaceutical K.K.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
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 demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).
Detailed Description
A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
CNTO 1959
Guselkumab
Placebo
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
192Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.
Drug: CNTO 1959 50 mg
Drug: Placebo 100 mg
Group 2
Experimental
Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.
Drug: CTNO 1959 100 mg
Drug: Placebo 50 mg
Group 3
Experimental
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
Drug: CNTO 1959 50 mg
Drug: CTNO 1959 100 mg
Drug: Placebo 50 mg
Drug: Placebo 100 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CNTO 1959 50 mg
Drug
Participants will receive subcutaneous injection of CNTO 1959 50 mg.
Group 1
Group 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 16
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved PASI 75 Response at 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline
Have an IGA >= 3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
Exclusion Criteria:
Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
Has a 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 and/or splenomegaly
Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Asahikawa
Japan
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (Controlled Period [CP])
Participants stratified by the type of psoriasis (with or without PsA) received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
Periods
Title
Milestones
Reasons Not Completed
Controlled Period (Week 0 - 16)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Guselkumab
CTNO 1959 100 mg
Drug
Participants will receive subcutaneous injection of CNTO 1959 100 mg.
Group 2
Group 3
Guselkumab
Placebo 50 mg
Drug
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.
Group 2
Group 3
Placebo 100 mg
Drug
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.
Group 1
Group 3
Week 16
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Baseline and Week 16
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Weeks 2, 4, 8, 12, and 16
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Weeks 2, 4, 8, 12, and 16
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Baseline and Weeks 2, 4, 8, 12, 16
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Baseline and Weeks 2, 4, 8, 12, 16
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (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 48
Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Baseline and Week 16
Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Baseline and Weeks 28, 36, 48, 52
Percent Change From Baseline in NAPSI Score at Week 16
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Baseline and Week 16
Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Baseline and Weeks 28, 36, 48, 52
Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16
The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Week 16
Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Week 28, 48 and 52
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Week 16
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Week 28, 48 and 52
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Weeks 8 and 16
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Weeks 28, 36, 48, and 52
Change From Baseline in the DLQI Total Score at Week 8
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Baseline and Weeks 8
Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Baseline and Weeks 28, 36, 48, 52
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Weeks 8 and 16
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Weeks 28, 36, 48, and 52
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16
The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline and Week 16
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48
The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline and Weeks 28, 48
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16
The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
Baseline and Week 16
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48
The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
Baseline and Weeks 28, 48
Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Baseline and Week 16
Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Baseline and Weeks 28, 48
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Baseline and Week 16
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Baseline and Weeks 28, 48
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Weeks 4, 8, and 16
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Weeks 28, 36, 48, and 52
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Weeks 4, 8, and 16
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Weeks 28, 36, 48, and 52
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Baseline and Weeks 4, 8, 16
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Baseline and Weeks 28, 36, 48, 52
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).
Baseline and Weeks 4, 8, 16
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Baseline and Weeks 28, 36, 48, 52
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 centimeter [cm]) to "very poor" (10 cm).
Baseline and Weeks 4, 8, 16
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 cm) to "very poor" (10 cm).
Baseline and Weeks 28, 36, 48, 52
Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Weeks 4, 8, and 16
Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Weeks 28, 36, 48, 52
Chūō
Japan
Gifu
Japan
Isehara
Japan
Izumo
Japan
Kanazawa
Japan
Kawasaki
Japan
Kita-Gun
Japan
Kochi
Japan
Kurume
Japan
Kyoto
Japan
Matsumoto
Japan
Miyagi
Japan
Morioka
Japan
Nagoya
Japan
Osaka
Japan
Ōsaka-sayama
Japan
Sapporo
Japan
Shimotsuke
Japan
Shinjuku-ku
Japan
Tokushima
Japan
Tokyo
Japan
Tōon
Japan
Tsu
Japan
Tsukuba
Japan
Ube
Japan
Yokosuka
Japan
FG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
FG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
FG003
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
FG004
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
FG00064 subjects
FG00165 subjects
FG00263 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00052 subjects
FG00163 subjects
FG00262 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00012 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG0006 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
After Controlled Period (Week 16 - 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00163 subjects
FG00262 subjects
FG00326 subjectsParticipants who completed CP and re-randomized to Guselkumab 50 mg.
FG00426 subjectsParticipants who completed CP and re-randomized to Guselkumab 100 mg.
COMPLETED
FG0000 subjects
FG00160 subjects
FG00262 subjects
FG00326 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
BG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
BG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00064
BG00165
BG00263
BG003192
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.3± 10.56
BG00150.1± 12.66
BG00247.8± 11.07
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00121
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Japan
Title
Measurements
BG00064
BG00165
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
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG0007.8
OG00192.3
OG00288.9
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
Fisher Exact
<0.001
Superiority
OG000
OG002
Fisher Exact
< 0.001
Primary
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved PASI 75 Response at 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Secondary
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
percent change
Baseline and Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
percent change
Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Secondary
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
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 is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Secondary
Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (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 analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
Change in BSA (% points)
Baseline and Week 48
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Population included participants randomized at Week 0 and with nail psoriasis at baseline.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in NAPSI Score at Week 16
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Population included participants randomized at Week 0 and with nail psoriasis at baseline.
Posted
Mean
Standard Deviation
percent change
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.
Posted
Mean
Standard Deviation
percent change
Baseline and Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16
The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Population included participants randomized at Week 0 and with baseline ss-IGA score >= 2.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score >= 2.
Posted
Number
percentage of participants
Week 28, 48 and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Population included participants randomized at Week 0 and with baseline ss-IGA score >= 2.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score >= 2
Posted
Number
percentage of participants
Week 28, 48 and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Population included participants randomized at Week 0 and with baseline DLQI > 1.
Posted
Number
percentage of participants
Weeks 8 and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline DLQI <=1.
Posted
Number
percentage of participants
Weeks 28, 36, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in the DLQI Total Score at Week 8
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 8
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Secondary
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Weeks 8 and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant'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. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Number
percentage of participants
Weeks 28, 36, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Secondary
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16
The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48
The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 28, 48
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16
The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48
The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 28, 48
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Secondary
Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 28, 48
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 28, 48
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.
Posted
Number
percentage of participants
Weeks 4, 8, and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
Secondary
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.
Posted
Number
percentage of participants
Weeks 28, 36, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
percent change
Weeks 4, 8, and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Secondary
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
percent change
Weeks 28, 36, 48, and 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.
Posted
Mean
Standard Deviation
joints
Baseline and Weeks 4, 8, 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Guselkumab 100 mg (CP)
Secondary
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.
Posted
Mean
Standard Deviation
joints
Baseline and Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).
Population included randomized participants at Week 0 and who had diagnosis of PsA at screening. Participants were analyzed according to assigned treatment they were randomized to, regardless of treatment they actually received. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline and Weeks 4, 8, 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percent change
Baseline and Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 centimeter [cm]) to "very poor" (10 cm).
Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline and Weeks 4, 8, 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 cm) to "very poor" (10 cm).
Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline and Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.
Posted
Number
percentage of participants
Weeks 4, 8, and 16
ID
Title
Description
OG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
Secondary
Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.
Posted
Number
percentage of participants
Weeks 28, 36, 48, 52
ID
Title
Description
OG000
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Time Frame
Up to Week 52
Description
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (CP)
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis [PsA]).
2
64
36
64
EG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12.
1
65
27
65
EG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12.
1
63
26
63
EG003
Guselkumab 50 mg (After CP)
Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44.
6
63
56
63
EG004
Guselkumab 100 mg (After CP)
Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44.
6
62
55
62
EG005
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
4
26
25
26
EG006
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
5
26
26
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina Pectoris
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG0031 affected63 at risk
EG0040 affected62 at risk
EG0050 affected26 at risk
EG0060 affected26 at risk
Atrial Fibrillation
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Cataract
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Diabetic Retinopathy
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Glaucoma
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Macular Hole
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Rhegmatogenous Retinal Detachment
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Vitreous Haemorrhage
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gastric Perforation
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gastric Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Bacterial Prostatitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pancreatic Abscess
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gouty Tophus
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Colon Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Metastases to the Mediastinum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Rectal Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Loss of Consciousness
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Seizure
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Thalamus Haemorrhage
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Varicose Vein
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG0031 affected63 at risk
EG0042 affected62 at risk
EG0053 affected26 at risk
EG0060 affected26 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Dermoid Cyst
Congenital, familial and genetic disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
External Ear Inflammation
Ear and labyrinth disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Corneal Disorder
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Visual Impairment
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0012 affected65 at risk
EG0021 affected63 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0022 affected63 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0021 affected63 at risk
EG003
Gastric Polyps
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Pancreatic Cyst
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pancreatitis Chronic
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Discolouration
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Erythema
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Hypertrichosis
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Hypertrophy
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Induration
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Pain
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Injection Site Swelling
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pyrexia
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hepatic Function Abnormal
Hepatobiliary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hepatitis Alcoholic
Hepatobiliary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Body Tinea
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Diarrhoea Infectious
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Folliculitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0012 affected65 at risk
EG0020 affected63 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Groin Abscess
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Helicobacter Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0012 affected65 at risk
EG0020 affected63 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0012 affected65 at risk
EG0020 affected63 at risk
EG003
Infectious Colitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Lice Infestation
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0007 affected64 at risk
EG00114 affected65 at risk
EG0028 affected63 at risk
EG003
Omphalitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0012 affected65 at risk
EG0020 affected63 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Tinea Cruris
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Tinea Pedis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0022 affected63 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Face Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Nerve Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Post-Traumatic Neck Syndrome
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0021 affected63 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Tooth Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Wound Complication
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
C-Reactive Protein Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Electrocardiogram Abnormal
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Electrocardiogram QT Prolonged
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hepatic Enzyme Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Liver Function Test Abnormal
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Weight Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Metabolic Disorder
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0012 affected65 at risk
EG0021 affected63 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Plantar Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Synovial Cyst
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Trigger Finger
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Blepharal Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Seborrhoeic Keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Post Herpetic Neuralgia
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Radial Nerve Palsy
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Speech Disorder
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Diabetic Nephropathy
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Nasal Mucosal Erosion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Pharyngeal Paraesthesia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0021 affected63 at risk
EG003
Upper Respiratory Tract Inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0012 affected65 at risk
EG0020 affected63 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Dyshidrotic Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Eczema Asteatotic
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Hand Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Palmoplantar Pustulosis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected64 at risk
EG0010 affected65 at risk
EG0021 affected63 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG00011 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0011 affected65 at risk
EG0020 affected63 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected64 at risk
EG0010 affected65 at risk
EG0020 affected63 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected64 at risk
EG0012 affected65 at risk
EG0020 affected63 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director
Janssen Pharmaceutical K.K., Japan
844-434-4210
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000588857
guselkumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
25 subjects
1 subjects
0 subjects
FG0041 subjects
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
48.8
± 11.46
16
BG00347
Male
BG00054
BG00144
BG00247
BG003145
63
BG003192
Superiority
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG0000
OG00170.8
OG00269.8
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
Fisher Exact
<0.001
Superiority
OG000
OG002
Fisher Exact
< 0.001
Superiority
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG0006.3
OG00189.2
OG00284.1
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG000-0.8± 5.40
OG001-8.3± 5.87
OG002-8.5± 6.95
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Week 2: IGA 0 responders
Title
Measurements
OG0000
OG0010
OG0020
Week 2: IGA 0/1 responders
Title
Measurements
OG0000
OG0013.1
OG0029.5
Week 2: IGA 0/1/2 responders
Title
Measurements
OG00010.9
OG00147.7
OG00246.0
Week 4: IGA 0 responders
Title
Measurements
OG0000
OG0011.5
OG0026.3
Week 4: IGA 0/1 responders
Title
Measurements
OG0001.6
OG00127.7
OG00225.4
Week 4: IGA 0/1/2 responders
Title
Measurements
OG00020.3
OG00181.5
OG00277.8
Week 8: IGA 0 responders
Title
Measurements
OG0000
OG00116.9
OG00220.6
Week 8: IGA 0/1 responders
Title
Measurements
OG0001.6
OG00176.9
OG00265.1
Week 8: IGA 0/1/2 responders
Title
Measurements
OG00020.3
OG00193.8
OG00293.7
Week 12: IGA 0 responders
Title
Measurements
OG0000
OG00133.8
OG00233.3
Week 12: IGA 0/1 responders
Title
Measurements
OG0004.7
OG00189.2
OG00284.1
Week 12: IGA 0/1/2 responders
Title
Measurements
OG00025.0
OG00195.4
OG00296.8
Week 16: IGA 0 responders
Title
Measurements
OG0000
OG00144.6
OG00244.4
Week 16: IGA 0/1 responders
Title
Measurements
OG0007.8
OG00192.3
OG00288.9
Week 16: IGA 0/1/2 responders
Title
Measurements
OG00028.1
OG00196.9
OG00296.8
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 20: IGA 0 responders
Title
Measurements
OG00046.2
OG00157.1
OG0023.8
OG00311.5
Week 20: IGA 0/1 responders
Title
Measurements
OG00089.2
OG00192.1
OG00257.7
OG003
Week 20: IGA 0/1/2 responders
Title
Measurements
OG00096.9
OG00196.8
OG00284.6
OG003
Week 24: IGA 0 responders
Title
Measurements
OG00053.8
OG00157.1
OG00215.4
OG003
Week 24: IGA 0/1 responders
Title
Measurements
OG00090.8
OG00188.9
OG00288.5
OG003
Week 24: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00196.8
OG00296.2
OG003
Week 28: IGA 0 responders
Title
Measurements
OG00053.8
OG00149.2
OG00250.0
OG003
Week 28: IGA 0/1 responders
Title
Measurements
OG00090.8
OG00188.9
OG002100.0
OG003
Week 28: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00195.2
OG002100.0
OG003
Week 32: IGA 0 responders
Title
Measurements
OG00047.7
OG00155.6
OG00253.8
OG003
Week 32: IGA 0/1 responders
Title
Measurements
OG00089.2
OG00190.5
OG002100.0
OG003
Week 32: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00196.8
OG002100.0
OG003
Week 36: IGA 0 responders
Title
Measurements
OG00044.6
OG00155.6
OG00261.5
OG003
Week 36: IGA 0/1 responders
Title
Measurements
OG00089.2
OG00190.5
OG002100.0
OG003
Week 36: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00196.8
OG002100.0
OG003
Week 40: IGA 0 responders
Title
Measurements
OG00049.2
OG00155.6
OG00265.4
OG003
Week 40: IGA 0/1 responders
Title
Measurements
OG00087.7
OG00192.1
OG002100.0
OG003
Week 40: IGA 0/1/2 responders
Title
Measurements
OG00096.9
OG00198.4
OG002100.0
OG003
Week 44: IGA 0 responders
Title
Measurements
OG00055.4
OG00152.4
OG00261.5
OG003
Week 44: IGA 0/1 responders
Title
Measurements
OG00086.2
OG00188.9
OG002100.0
OG003
Week 44: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00196.8
OG002100.0
OG003
Week 48: IGA 0 responders
Title
Measurements
OG00050.8
OG00160.3
OG00273.1
OG003
Week 48: IGA 0/1 responders
Title
Measurements
OG00086.2
OG00187.3
OG002100.0
OG003
Week 48: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00196.8
OG002100.0
OG003
Week 52: IGA 0 responders
Title
Measurements
OG00053.8
OG00158.7
OG00253.8
OG003
Week 52: IGA 0/1 responders
Title
Measurements
OG00087.7
OG00190.5
OG002100.0
OG003
Week 52: IGA 0/1/2 responders
Title
Measurements
OG00098.5
OG00198.4
OG002100.0
OG003
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Week 2: PASI 50 responders
Title
Measurements
OG0000
OG0014.6
OG00217.5
Week 2: PASI 75 responders
Title
Measurements
OG0000
OG0010
OG0021.6
Week 2: PASI 90 responders
Title
Measurements
OG0000
OG0010
OG0020
Week 2: PASI 100 responders
Title
Measurements
OG0000
OG0010
OG0020
Week 4: PASI 50 responders
Title
Measurements
OG0001.6
OG00149.2
OG00249.2
Week 4: PASI 75 responders
Title
Measurements
OG0000
OG00115.4
OG00217.5
Week 4: PASI 90 responders
Title
Measurements
OG0000
OG0014.6
OG0024.8
Week 4: PASI 100 responders
Title
Measurements
OG0000
OG0011.5
OG0021.6
Week 8: PASI 50 responders
Title
Measurements
OG0009.4
OG00187.7
OG00279.4
Week 8: PASI 75 responders
Title
Measurements
OG0000
OG00155.4
OG00250.8
Week 8: PASI 90 responders
Title
Measurements
OG0000
OG00130.8
OG00230.2
Week 8: PASI 100 responders
Title
Measurements
OG0000
OG0017.7
OG0027.9
Week 12: PASI 50 responders
Title
Measurements
OG0007.8
OG00190.8
OG00292.1
Week 12: PASI 75 responders
Title
Measurements
OG0003.1
OG00178.5
OG00279.4
Week 12: PASI 90 responders
Title
Measurements
OG0000
OG00147.7
OG00238.1
Week 12: PASI 100 responders
Title
Measurements
OG0000
OG00116.9
OG00222.2
Week 16: PASI 50 responders
Title
Measurements
OG00014.1
OG00193.8
OG00295.2
Week 16: PASI 75 responders
Title
Measurements
OG0006.3
OG00189.2
OG00284.1
Week 16: PASI 90 responders
Title
Measurements
OG0000
OG00170.8
OG00269.8
Week 16: PASI 100 responders
Title
Measurements
OG0000
OG00132.3
OG00227.0
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 20: PASI 50 responders
Title
Measurements
OG00095.4
OG00196.8
OG00257.7
OG00365.4
Week 20: PASI 75 responders
Title
Measurements
OG00090.8
OG00188.9
OG00246.2
OG003
Week 20: PASI 90 responders
Title
Measurements
OG00070.8
OG00171.4
OG00219.2
OG003
Week 20: PASI 100 responders
Title
Measurements
OG00033.8
OG00134.9
OG0023.8
OG003
Week 24: PASI 50 responders
Title
Measurements
OG00098.5
OG00198.4
OG00292.3
OG003
Week 24: PASI 75 responders
Title
Measurements
OG00090.8
OG00190.5
OG00280.8
OG003
Week 24: PASI 90 responders
Title
Measurements
OG00078.5
OG00176.2
OG00242.3
OG003
Week 24: PASI 100 responders
Title
Measurements
OG00041.5
OG00144.4
OG00211.5
OG003
Week 28: PASI 50 responders
Title
Measurements
OG00098.5
OG00198.4
OG002100.0
OG003
Week 28: PASI 75 responders
Title
Measurements
OG00092.3
OG00190.5
OG00288.5
OG003
Week 28: PASI 90 responders
Title
Measurements
OG00075.4
OG00177.8
OG00273.1
OG003
Week 28: PASI 100 responders
Title
Measurements
OG00044.6
OG00138.1
OG00230.8
OG003
Week 32: PASI 50 responders
Title
Measurements
OG00098.5
OG00198.4
OG002100.0
OG003
Week 32: PASI 75 responders
Title
Measurements
OG00092.3
OG00190.5
OG00292.3
OG003
Week 32: PASI 90 responders
Title
Measurements
OG00076.9
OG00176.2
OG00276.9
OG003
Week 32: PASI 100 responders
Title
Measurements
OG00041.5
OG00144.4
OG00234.6
OG003
Week 36: PASI 50 responders
Title
Measurements
OG00098.5
OG00195.2
OG002100.0
OG003
Week 36: PASI 75 responders
Title
Measurements
OG00092.3
OG00190.5
OG00296.2
OG003
Week 36: PASI 90 responders
Title
Measurements
OG00078.5
OG00176.2
OG00284.6
OG003
Week 36: PASI 100 responders
Title
Measurements
OG00036.9
OG00142.9
OG00230.8
OG003
Week 40: PASI 50 responders
Title
Measurements
OG00098.5
OG00198.4
OG002100.0
OG003
Week 40: PASI 75 responders
Title
Measurements
OG00090.8
OG00190.5
OG002100.0
OG003
Week 40: PASI 90 responders
Title
Measurements
OG00078.5
OG00177.8
OG00296.2
OG003
Week 40: PASI 100 responders
Title
Measurements
OG00033.8
OG00144.4
OG00238.5
OG003
Week 44: PASI 50 responders
Title
Measurements
OG00098.5
OG00195.2
OG002100.0
OG003
Week 44: PASI 75 responders
Title
Measurements
OG00090.8
OG00188.9
OG002100.0
OG003
Week 44: PASI 90 responders
Title
Measurements
OG00080.0
OG00174.6
OG00288.5
OG003
Week 44: PASI 100 responders
Title
Measurements
OG00038.5
OG00144.4
OG00242.3
OG003
Week 48: PASI 50 responders
Title
Measurements
OG00098.5
OG00196.8
OG002100.0
OG003
Week 48: PASI 75 responders
Title
Measurements
OG00090.8
OG00193.7
OG002100.0
OG003
Week 48: PASI 90 responders
Title
Measurements
OG00075.4
OG00177.8
OG002100.0
OG003
Week 48: PASI 100 responders
Title
Measurements
OG00036.9
OG00149.2
OG00246.2
OG003
Week 52: PASI 50 responders
Title
Measurements
OG00098.5
OG00198.4
OG002100.0
OG003
Week 52: PASI 75 responders
Title
Measurements
OG00092.3
OG00190.5
OG002100.0
OG003
Week 52: PASI 90 responders
Title
Measurements
OG00075.4
OG00177.8
OG00292.3
OG003
Week 52: PASI 100 responders
Title
Measurements
OG00038.5
OG00147.6
OG00238.5
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.4± 18.55
OG00120.1± 20.85
OG00223.6± 23.76
Week 4
Title
Measurements
OG0000.0± 27.74
OG00145.3± 26.72
OG00244.9± 30.80
Week 8
Title
Measurements
OG0001.5± 32.73
OG00174.5± 22.39
OG00270.3± 25.42
Week 12
Title
Measurements
OG0000.5± 38.28
OG00183.7± 20.00
OG00282.9± 18.56
Week 16
Title
Measurements
OG0000.2± 45.53
OG00188.9± 17.34
OG00288.7± 17.77
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 20
Title
Measurements
OG00089.4± 18.21
OG00190.6± 16.45
OG00258.7± 33.67
OG00351.9± 39.06
Week 24
Title
Measurements
OG00091.6± 14.59
OG00192.1± 15.51
OG00280.7± 24.87
OG003
Week 28
Title
Measurements
OG00091.9± 14.05
OG00191.4± 16.24
OG00291.6± 10.81
OG003
Week 32
Title
Measurements
OG00092.5± 12.38
OG00192.0± 15.78
OG00293.1± 8.59
OG003
Week 36
Title
Measurements
OG00092.2± 13.42
OG00190.5± 19.40
OG00294.7± 6.76
OG003
Week 40
Title
Measurements
OG00092.3± 13.86
OG00192.1± 15.86
OG00296.4± 3.87
OG003
Week 44
Title
Measurements
OG00091.8± 17.30
OG00191.1± 17.26
OG00296.6± 4.39
OG003
Week 48
Title
Measurements
OG00091.5± 17.28
OG00192.1± 16.14
OG00297.9± 2.73
OG003
Week 52
Title
Measurements
OG00091.6± 17.12
OG00192.5± 15.39
OG00296.7± 4.45
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.0± 4.44
OG001-5.7± 7.13
OG002-6.3± 7.17
Week 4
Title
Measurements
OG000-0.2± 7.13
OG001-12.1± 10.55
OG002-12.5± 11.00
Week 8
Title
Measurements
OG000-1.0± 8.99
OG001-19.1± 10.62
OG002-19.2± 11.80
Week 12
Title
Measurements
OG000-0.6± 10.62
OG001-21.4± 11.11
OG002-22.4± 11.86
Week 16
Title
Measurements
OG000-0.5± 12.39
OG001-22.6± 11.00
OG002-23.9± 12.27
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 20
Title
Measurements
OG000-22.8± 11.23
OG001-24.3± 12.52
OG002-18.3± 15.46
OG003-11.3± 10.33
Week 24
Title
Measurements
OG000-23.4± 11.16
OG001-24.7± 12.35
OG002-24.2± 15.12
OG003
Week 28
Title
Measurements
OG000-23.6± 11.44
OG001-24.5± 12.56
OG002-27.0± 14.84
OG003
Week 32
Title
Measurements
OG000-23.7± 11.30
OG001-24.7± 12.58
OG002-27.6± 15.02
OG003
Week 36
Title
Measurements
OG000-23.6± 11.38
OG001-24.3± 12.72
OG002-28.0± 15.02
OG003
Week 40
Title
Measurements
OG000-23.7± 11.51
OG001-24.6± 12.29
OG002-28.4± 14.96
OG003
Week 44
Title
Measurements
OG000-23.5± 11.69
OG001-24.3± 12.29
OG002-28.5± 15.04
OG003
Week 48
Title
Measurements
OG000-23.4± 11.59
OG001-24.6± 12.27
OG002-28.7± 14.90
OG003
Week 52
Title
Measurements
OG000-23.5± 11.74
OG001-24.6± 12.11
OG002-28.5± 15.07
OG003
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Title
Measurements
OG000-31.7± 22.40
OG001-34.4± 21.19
OG002-37.1± 22.24
OG003-27.7± 16.08
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00042
OG00144
OG00240
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 1.13
OG001-1.2± 1.61
OG002-1.5± 1.78
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00044
OG00140
OG00215
OG00318
Title
Denominators
Categories
Week 28
Title
Measurements
OG000-2.2± 1.79
OG001-2.4± 2.34
OG002-1.7± 1.40
OG003-0.7± 1.13
Week 36
Title
Measurements
OG000-2.3± 2.01
OG001-2.7± 2.23
OG002-2.5± 1.77
OG003
Week 48
Title
Measurements
OG000-2.7± 1.91
OG001-2.7± 2.44
OG002-3.3± 2.22
OG003
Week 52
Title
Measurements
OG000-2.8± 1.94
OG001-2.7± 2.20
OG002-3.3± 2.34
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00042
OG00144
OG00240
Title
Denominators
Categories
Title
Measurements
OG0001.0± 59.38
OG00131.6± 43.56
OG00239.1± 48.93
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00044
OG00140
OG00215
OG00318
Title
Denominators
Categories
Week 28
Title
Measurements
OG00057.9± 42.99
OG00161.1± 43.15
OG00248.7± 38.77
OG00323.6± 49.69
Week 36
Title
Measurements
OG00059.6± 46.95
OG00167.4± 45.44
OG00269.9± 30.48
OG003
Week 48
Title
Measurements
OG00071.0± 37.11
OG00168.1± 49.01
OG00280.2± 23.06
OG003
Week 52
Title
Measurements
OG00074.4± 35.11
OG00175.3± 41.32
OG00279.2± 25.62
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00057
OG00158
OG00258
Title
Denominators
Categories
Title
Measurements
OG00010.5
OG00174.1
OG00282.8
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00058
OG00158
OG00221
OG00324
Title
Denominators
Categories
Week 28
Title
Measurements
OG00086.2
OG00186.2
OG00290.5
OG00370.8
Week 48
Title
Measurements
OG00084.5
OG00184.5
OG00285.7
OG003
Week 52
Title
Measurements
OG00084.5
OG00186.2
OG00285.7
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00057
OG00158
OG00258
Title
Denominators
Categories
Absence of Disease (0)
Title
Measurements
OG0003.5
OG00148.3
OG00263.8
Very Mild Disease (1)
Title
Measurements
OG0008.8
OG00141.4
OG00222.4
Mild Disease (2)
Title
Measurements
OG00021.1
OG0018.6
OG0028.6
Moderate Disease (3)
Title
Measurements
OG00049.1
OG0011.7
OG0025.2
Severe Disease (4)
Title
Measurements
OG00017.5
OG0010
OG0020
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00058
OG00158
OG00221
OG00324
Title
Denominators
Categories
Week 28: Absence of Disease (0)
Title
Measurements
OG00063.8
OG00170.7
OG00266.7
OG00350.0
Week 28: Very Mild Disease (1)
Title
Measurements
OG00031.0
OG00122.4
OG00228.6
OG003
Week 28: Mild Disease (2)
Title
Measurements
OG0003.4
OG0013.4
OG0024.8
OG003
Week 28: Moderate Disease (3)
Title
Measurements
OG0001.7
OG0013.4
OG0020
OG003
Week 28: Severe Disease (4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 48: Absence of Disease (0)
Title
Measurements
OG00067.2
OG00175.9
OG00276.2
OG003
Week 48: Very Mild Disease (1)
Title
Measurements
OG00025.9
OG00113.8
OG0029.5
OG003
Week 48: Mild Disease (2)
Title
Measurements
OG0005.2
OG0016.9
OG0029.5
OG003
Week 48: Moderate Disease (3)
Title
Measurements
OG0001.7
OG0013.4
OG0024.8
OG003
Week 48: Severe Disease (4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 52: Absence of Disease (0)
Title
Measurements
OG00067.2
OG00177.6
OG00266.7
OG003
Week 52: Very Mild Disease (1)
Title
Measurements
OG00027.6
OG00110.3
OG00219.0
OG003
Week 52: Mild Disease (2)
Title
Measurements
OG0003.4
OG00110.3
OG00214.3
OG003
Week 52: Moderate Disease (3)
Title
Measurements
OG0001.7
OG0011.7
OG0020
OG003
Week 52: Severe Disease (4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00061
OG00164
OG00260
Title
Denominators
Categories
Week 8
Title
Measurements
OG0006.6
OG00143.8
OG00243.3
Week 16
Title
Measurements
OG0006.6
OG00164.1
OG00268.3
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00064
OG00160
OG00224
OG00325
Title
Denominators
Categories
Week 28
Title
Measurements
OG00070.3
OG00175.0
OG00250.0
OG00368.0
Week 36
Title
Measurements
OG00079.7
OG00183.3
OG00279.2
OG003
Week 48
Title
Measurements
OG00073.4
OG00173.3
OG00262.5
OG003
Week 52
Title
Measurements
OG00073.4
OG00176.7
OG00275.0
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG000-0.4± 4.71
OG001-7.5± 5.28
OG002-7.0± 6.35
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 28
Title
Measurements
OG000-9.0± 5.85
OG001-8.9± 6.95
OG002-9.5± 7.73
OG003-5.5± 5.19
Week 36
Title
Measurements
OG000-9.2± 6.44
OG001-9.2± 7.27
OG002-10.3± 8.01
OG003
Week 48
Title
Measurements
OG000-9.2± 6.20
OG001-9.1± 7.12
OG002-10.1± 7.94
OG003
Week 52
Title
Measurements
OG000-9.2± 6.39
OG001-9.0± 7.28
OG002-10.1± 7.79
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Week 8
Title
Measurements
OG00017.2
OG00161.5
OG00258.7
Week 16
Title
Measurements
OG00020.3
OG00167.7
OG00269.8
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 28
Title
Measurements
OG00069.2
OG00173.0
OG00265.4
OG00357.7
Week 36
Title
Measurements
OG00072.3
OG00168.3
OG00269.2
OG003
Week 48
Title
Measurements
OG00072.3
OG00171.4
OG00269.2
OG003
Week 52
Title
Measurements
OG00072.3
OG00171.4
OG00269.2
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG0000.05± 0.141
OG0010.20± 0.199
OG0020.18± 0.210
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 28
Title
Measurements
OG0000.20± 0.187
OG0010.20± 0.221
OG0020.25± 0.170
OG0030.14± 0.133
Week 48
Title
Measurements
OG0000.20± 0.198
OG0010.21± 0.228
OG0020.28± 0.152
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG0002.45± 22.440
OG00121.20± 23.542
OG00218.43± 26.206
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 28
Title
Measurements
OG00022.94± 24.759
OG00120.87± 26.465
OG00220.73± 20.095
OG00311.62± 26.831
Week 48
Title
Measurements
OG00020.88± 29.647
OG00121.70± 26.577
OG00220.38± 22.094
OG003
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
PCS
Title
Measurements
OG0000.3± 9.90
OG0017.4± 15.65
OG0027.3± 14.40
MCS
Title
Measurements
OG0001.3± 8.21
OG0014.0± 7.22
OG0025.3± 9.63
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 28: PCS
Title
Measurements
OG0007.7± 13.71
OG0018.9± 14.83
OG0026.4± 10.20
OG0035.4± 9.80
Week 48: PCS
Title
Measurements
OG0008.2± 14.22
OG0018.4± 15.16
OG0028.8± 12.13
OG003
Week 28: MCS
Title
Measurements
OG0005.9± 9.62
OG0014.6± 10.30
OG0026.5± 6.91
OG003
Week 48: MCS
Title
Measurements
OG0005.7± 9.04
OG0015.6± 9.32
OG0024.5± 9.92
OG003
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00064
OG00165
OG00263
Title
Denominators
Categories
Absenteeism
ParticipantsOG00058
ParticipantsOG00155
ParticipantsOG00251
Title
Measurements
OG0000.9± 14.96
OG001-2.4± 8.14
OG002-1.9± 8.18
Activity Impairment
ParticipantsOG00064
ParticipantsOG00165
ParticipantsOG00263
Title
Measurements
OG000
Presenteeism
ParticipantsOG00058
ParticipantsOG00154
ParticipantsOG00251
Title
Measurements
OG000
Work Productivity Loss
ParticipantsOG00058
ParticipantsOG00154
ParticipantsOG00251
Title
Measurements
OG000
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00065
OG00163
OG00226
OG00326
Title
Denominators
Categories
Week 28: Absenteeism
ParticipantsOG00055
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00323
Title
Measurements
OG000-3.0± 10.93
OG001-2.8± 9.12
OG002-4.0± 8.78
OG003
Week 28: Activity Impairment
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00226
ParticipantsOG00326
Week 28: Presenteeism
ParticipantsOG00054
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00323
Week 28: Work Productivity Loss
ParticipantsOG00054
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00323
Week 48: Absenteeism
ParticipantsOG00055
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00323
Week 48: Activity Impairment
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00226
ParticipantsOG00326
Week 48: Presenteeism
ParticipantsOG00054
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00323
Week 48: Work Productivity Loss
ParticipantsOG00054
ParticipantsOG00151
ParticipantsOG00224
ParticipantsOG00323
OG001
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00010
OG00111
OG00210
Title
Denominators
Categories
Week 4: ACR 20 responders
Title
Measurements
OG0000
OG00127.3
OG00210.0
Week 4: ACR 50 responders
Title
Measurements
OG0000
OG00118.2
OG0020
Week 4: ACR 70 responders
Title
Measurements
OG0000
OG0019.1
OG0020
Week 8: ACR 20 responders
Title
Measurements
OG00010.0
OG00145.5
OG00220.0
Week 8: ACR 50 responders
Title
Measurements
OG0000
OG00136.4
OG00220.0
Week 8: ACR 70 responders
Title
Measurements
OG0000
OG00118.2
OG0020
Week 16: ACR 20 responders
Title
Measurements
OG0000
OG00145.5
OG00230.0
Week 16: ACR 50 responders
Title
Measurements
OG0000
OG00118.2
OG00230.0
Week 16: ACR 70 responders
Title
Measurements
OG0000
OG0019.1
OG00230.0
OG001
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00011
OG00110
OG0023
OG0034
Title
Denominators
Categories
Week 28: ACR 20 responders
Title
Measurements
OG00036.4
OG00140.0
OG00266.7
OG0030
Week 28: ACR 50 responders
Title
Measurements
OG00027.3
OG00140.0
OG00233.3
OG003
Week 28: ACR 70 responders
Title
Measurements
OG00018.2
OG00130.0
OG00233.3
OG003
Week 36: ACR 20 responders
Title
Measurements
OG00045.5
OG00140.0
OG00266.7
OG003
Week 36: ACR 50 responders
Title
Measurements
OG00036.4
OG00140.0
OG00266.7
OG003
Week 36: ACR 70 responders
Title
Measurements
OG00027.3
OG00140.0
OG00233.3
OG003
Week 48: ACR 20 responders
Title
Measurements
OG00045.5
OG00130.0
OG00266.7
OG003
Week 48: ACR 50 responders
Title
Measurements
OG00045.5
OG00130.0
OG00266.7
OG003
Week 48: ACR 70 responders
Title
Measurements
OG00036.4
OG00130.0
OG00266.7
OG003
Week 52: ACR 20 responders
Title
Measurements
OG00054.5
OG00120.0
OG00266.7
OG003
Week 52: ACR 50 responders
Title
Measurements
OG00036.4
OG00120.0
OG00266.7
OG003
Week 52: ACR 70 responders
Title
Measurements
OG00027.3
OG00120.0
OG00266.7
OG003
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00010
OG00111
OG00210
Title
Denominators
Categories
Week 4: Tender joints
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00210
Title
Measurements
OG000-7.4± 22.22
OG00141.1± 34.47
OG002-8.8± 117.56
Week 4: Swollen joints
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0026
Title
Measurements
OG000
Week 8: Tender joints
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
Title
Measurements
OG000
Week 8: Swollen joints
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0026
Title
Measurements
OG000
Week 16: Tender joints
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
Title
Measurements
OG000
Week 16: Swollen joints
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0026
Title
Measurements
OG000
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00011
OG00110
OG0023
OG0034
Title
Denominators
Categories
Week 28: Tender joints
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0023
ParticipantsOG0034
Title
Measurements
OG00054.9± 41.34
OG00160.6± 46.80
OG00233.3± 76.38
OG003
Week 28: Swollen joint
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Week 36: Tender joints
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0023
ParticipantsOG0034
Week 36: Swollen joint
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Week 48: Tender joints
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0023
ParticipantsOG0034
Week 48: Swollen joint
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Week 52: Tender joints
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0023
ParticipantsOG0034
Week 52: Swollen joint
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00010
OG00111
OG00210
Title
Denominators
Categories
Week 4: Tender joints
Title
Measurements
OG0000.2± 0.63
OG001-3.8± 6.15
OG002-1.6± 4.74
Week 4: Swollen joints
Title
Measurements
OG000-0.4± 0.97
OG001-1.2± 2.44
OG002-0.4± 1.58
Week 8: Tender joints
Title
Measurements
OG0000.9± 3.38
OG001-4.9± 9.24
OG002-2.6± 4.79
Week 8: Swollen joints
Title
Measurements
OG000-1.9± 4.68
OG001-2.1± 2.55
OG002-2.2± 3.43
Week 16: Tender joints
Title
Measurements
OG0001.3± 2.06
OG001-3.9± 6.32
OG002-3.3± 5.17
Week 16: Swollen joints
Title
Measurements
OG000-1.3± 3.56
OG001-2.3± 3.41
OG002-3.2± 4.37
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00011
OG00110
OG0023
OG0034
Title
Denominators
Categories
Week 28: Tender joints
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Title
Measurements
OG000-4.0± 6.03
OG001-4.1± 5.93
OG002-1.0± 2.00
OG003
Week 28: Swollen joint
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Week 36: Tender joints
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Week 36: Swollen joint
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Week 48: Tender joints
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Week 48: Swollen joint
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Week 52: Tender joints
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0023
ParticipantsOG0034
Week 52: Swollen joint
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00010
OG00111
OG0027
Title
Denominators
Categories
Week 4
Title
Measurements
OG00013.70± 23.698
OG0013.99± 78.918
OG00210.32± 118.053
Week 8
Title
Measurements
OG0002.36± 37.869
OG00138.19± 43.951
OG00245.15± 55.679
Week 16
Title
Measurements
OG000-0.73± 33.066
OG00145.51± 34.419
OG00262.11± 41.719
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00011
OG0017
OG0023
OG0034
Title
Denominators
Categories
Week 28
Title
Measurements
OG000-37.67± 339.724
OG00173.28± 28.687
OG00251.18± 30.418
OG00340.96± 73.340
Week 36
Title
Measurements
OG000-26.65± 273.745
OG00168.21± 40.538
OG00271.92± 21.156
OG003
Week 48
Title
Measurements
OG00050.38± 74.874
OG00157.65± 34.861
OG00281.36± 12.019
OG003
Week 52
Title
Measurements
OG000-30.54± 305.279
OG00162.09± 40.678
OG00277.06± 23.487
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00010
OG00111
OG0026
Title
Denominators
Categories
Week 4
Title
Measurements
OG00012.55± 24.547
OG00139.64± 38.514
OG00258.81± 29.281
Week 8
Title
Measurements
OG0002.50± 34.402
OG00144.50± 39.328
OG00263.10± 42.085
Week 16
Title
Measurements
OG000-6.52± 28.037
OG00121.38± 71.545
OG00275.70± 34.106
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
Units
Counts
Participants
OG00011
OG0016
OG0023
OG0034
Title
Denominators
Categories
Week 28
Title
Measurements
OG000-46.83± 346.499
OG00171.26± 35.552
OG00245.85± 35.019
OG00361.23± 16.062
Week 36
Title
Measurements
OG000-48.87± 341.563
OG00175.55± 33.992
OG00251.95± 27.007
OG003
Week 48
Title
Measurements
OG00043.09± 109.254
OG00158.36± 41.137
OG00276.02± 24.470
OG003
Week 52
Title
Measurements
OG000-20.17± 298.482
OG00166.00± 36.151
OG00271.59± 34.140
OG003
OG002
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
Units
Counts
Participants
OG00010
OG00111
OG00210
Title
Denominators
Categories
Week 4
Title
Measurements
OG00010.0
OG00136.4
OG00210.0
Week 8
Title
Measurements
OG00020.0
OG00145.5
OG00220.0
Week 16
Title
Measurements
OG0000
OG00154.5
OG00230.0
OG002
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
OG003
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.