A Study of Guselkumab in the Treatment of Participants Wi... | NCT02207244 | Trialant
NCT02207244
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Jul 22, 2021Actual
Enrollment
992Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Guselkumab 100 mg
Placebo for guselkumab
Adalimumab
Placebo for adalimumab
Countries
United States
Australia
Canada
Czechia
Germany
Poland
Russia
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT02207244
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR105048
Secondary IDs
ID
Type
Description
Link
CNTO1959PSO3002
Other Identifier
Janssen Research & Development, LLC
2014-000720-18
EudraCT Number
Brief Title
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment
Acronym
VOYAGE 2
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jun 2021
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
Nov 3, 2014Actual
Primary Completion Date
Oct 1, 2015Actual
Completion Date
Jul 1, 2020Actual
First Submitted Date
Jul 31, 2014
First Submission Date that Met QC Criteria
Jul 31, 2014
First Posted Date
Aug 4, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 4, 2017
Results First Submitted that Met QC Criteria
Sep 28, 2017
Results First Posted Date
Nov 6, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 12, 2016
Certification/Extension First Submitted that Passed QC Review
Jul 12, 2016
Certification/Extension First Posted Date
Jul 14, 2016Estimated
Last Update Submitted Date
Jun 29, 2021
Last Update Posted Date
Jul 22, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).
Detailed Description
This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab. The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at Week 264 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 264 visit. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
Plaque-type psoriasis
Guselkumab
Adalimumab
CNTO 1959
Monoclonal antibody
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
992Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group I
Experimental
Participants will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20. Starting at Week 28, participants will receive guselkumab 100 mg or placebo through Week 72 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab [two 0.8 milliliter (mL) injections] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind. All participants will receive guselkumab q8w starting at Week 76 through Week 252.
Drug: Guselkumab 100 mg
Drug: Placebo for guselkumab
Drug: Placebo for adalimumab
Group II
Placebo Comparator
Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. Placebo for adalimumab (two 0.8 mL injections) at week 0, followed by one 0.8 mL injection at weeks 1, 3, and 5, and q2w through week 23. At week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg or placebo through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.
Drug: Guselkumab 100 mg
Drug: Placebo for guselkumab
Drug: Placebo for adalimumab
Group III
Active Comparator
Participants will receive adalimumab 80 mg (two 40 mg [0.8 mL] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20. Participants will receive guselkumab or placebo starting at week 28 through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Guselkumab 100 mg
Drug
100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group 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 Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Must be a candidate for either systemic therapy or phototherapy for psoriasis
Exclusion Criteria:
Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Participants who have ever received guselkumab or adalimumab
History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, ThaÒ«i D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).
Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).
Group I
Group II
Group III
Adalimumab
Drug
80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.
Group III
HUMIRA®
Placebo for adalimumab
Drug
Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
Group I
Group II
Week 24
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
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 24
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 24
Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.
Through Week 48
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
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, Week 16
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group 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 Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Week 16
Percentage of Participants Who Achieved 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 in the Guselkumab Group Compared to the Placebo Group
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.
Week 16
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
Baseline and Week 16
Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
Week 24
Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.
Through Week 72
Percentage of Participants Who Achieved PASI 90 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved PASI 75 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
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). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
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. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Bakersfield
California
United States
Los Angeles
California
United States
San Diego
California
United States
Santa Monica
California
United States
Aurora
Colorado
United States
Coral Gables
Florida
United States
Tampa
Florida
United States
Newnan
Georgia
United States
Sandy Springs
Georgia
United States
Chicago
Illinois
United States
Rolling Meadows
Illinois
United States
Skokie
Illinois
United States
Indianapolis
Indiana
United States
Plainfield
Indiana
United States
Louisville
Kentucky
United States
Andover
Massachusetts
United States
Fort Gratiot
Michigan
United States
Troy
Michigan
United States
St Louis
Missouri
United States
Albuquerque
New Mexico
United States
New York
New York
United States
Gahanna
Ohio
United States
Norman
Oklahoma
United States
Portland
Oregon
United States
Pittsburgh
Pennsylvania
United States
Johnston
Rhode Island
United States
Arlington
Texas
United States
Houston
Texas
United States
Salt Lake City
Utah
United States
Seattle
Washington
United States
Spokane
Washington
United States
Benowa
Australia
Hectorville
Australia
Melbourne
Australia
Parkville
Australia
Westmead
Australia
Woolloongabba
Australia
Barrie
Ontario
Canada
Hamilton
Ontario
Canada
Mississauga
Ontario
Canada
Ottawa
Ontario
Canada
Richmond Hill
Ontario
Canada
Toronto
Ontario
Canada
Waterloo
Ontario
Canada
Windsor
Ontario
Canada
Jihlava
Czechia
Náchod
Czechia
Pardubice
Czechia
Pilsen
Czechia
Prague
Czechia
Ústà nad Labem
Czechia
Dresden
Germany
Gera
Germany
Hamburg
Germany
Kiel
Germany
Leipzig
Germany
Lübeck
Germany
Münster
Germany
Tübingen
Germany
Witten
Germany
Bialystok
Poland
Bydgoszcz
Poland
Gdansk
Poland
Krakow
Poland
Lodz
Poland
Lublin
Poland
Olsztyn
Poland
Poznan
Poland
Torun
Poland
Warsaw
Poland
Wroclaw
Poland
Chelyabinsk
Russia
Cherepovets
Russia
Moscow
Russia
Rostov-on-Don
Russia
Ryazan
Russia
Saint Petersburg
Russia
Yaroslavl
Russia
Busan
South Korea
Daejeon
South Korea
Gwangju
South Korea
Incheon
South Korea
Seongnam
South Korea
Seoul
South Korea
Suwon
South Korea
Badalona
Spain
Barcelona
Spain
Bilbao Vizcaya
Spain
Madrid
Spain
Murcia
Spain
Pontevedra
Spain
Valencia
Spain
Derived
Kim BS, Jo SJ, Youn S, Reich K, Saadoun C, Chang CL, Yang YW, Huang YH, Tsai TF. Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2. Dermatol Ther (Heidelb). 2023 Nov;13(11):2721-2737. doi: 10.1007/s13555-023-01026-7. Epub 2023 Sep 26.
Tillett W, Egeberg A, Sonkoly E, Gorecki P, Tjarnlund A, Buyze J, Wegner S, McGonagle D. Nail psoriasis dynamics during biologic treatment and withdrawal in patients with psoriasis who may be at high risk of developing psoriatic arthritis: a post hoc analysis of the VOYAGE 2 randomized trial. Arthritis Res Ther. 2023 Sep 15;25(1):169. doi: 10.1186/s13075-023-03138-z.
Orbai AM, Chakravarty SD, You Y, Shawi M, Yang YW, Merola JF. Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2859-2868. doi: 10.1007/s13555-023-01012-z. Epub 2023 Sep 15.
Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, You Y, Han C, Yang YW, Foley P, Griffiths CEM. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.
Reich K, Armstrong AW, Foley P, Song M, Miller M, Shen YK, You Y, Han C, Gordon KB. Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study. Am J Clin Dermatol. 2020 Dec;21(6):881-890. doi: 10.1007/s40257-020-00555-7.
Gordon KB, Armstrong AW, Foley P, Song M, Shen YK, Li S, Munoz-Elias EJ, Branigan P, Liu X, Reich K. Guselkumab Efficacy after Withdrawal Is Associated with Suppression of Serum IL-23-Regulated IL-17 and IL-22 in Psoriasis: VOYAGE 2 Study. J Invest Dermatol. 2019 Dec;139(12):2437-2446.e1. doi: 10.1016/j.jid.2019.05.016. Epub 2019 Jun 15.
Reich K, Papp KA, Armstrong AW, Wasfi Y, Li S, Shen YK, Randazzo B, Song M, Kimball AB. Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies. Br J Dermatol. 2019 May;180(5):1039-1049. doi: 10.1111/bjd.17454.
Armstrong AW, Reich K, Foley P, Han C, Song M, Shen YK, You Y, Papp KA. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies. Am J Clin Dermatol. 2019 Feb;20(1):155-164. doi: 10.1007/s40257-018-0396-z.
Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, Li S, Shen YK, Blauvelt A. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018 Jun 1;154(6):676-683. doi: 10.1001/jamadermatol.2018.0793.
FG001
Guselkumab 100 mg (Week 0 - 16)
Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.
FG002
Adalimumab (Week 0 - 16)
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.
FG003
Placebo Then Guselkumab 100 mg (Week 16 - 28)
Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).
FG004
Guselkumab 100 mg (Week 16 - 28)
Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
FG005
Adalimumab (Week 16 - 28)
Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
FG006
Placebo Then Guselkumab 100 mg (Week 28 - 264)
Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
FG007
Guselkumab 100 mg (Week 28 - 264)
Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
FG008
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
FG009
Adalimumab (After ACP)
Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of >=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.
FG010
Guselkumab Combined
All participants who received guselkumab 100 mg subcutaneously q8w at Week 76 and thereafter through Week 252.
FG000248 subjects
FG001496 subjects
FG002248 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Treated
FG000248 subjects
FG001494 subjects
FG002248 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG000233 subjects
FG001478 subjects
FG002237 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG00015 subjects
FG00118 subjects
FG00211 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0019 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lack of Efficacy
FG0004 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0007 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Noncompliance
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
OTHER
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Placebo Crossover and ACP: Week 16-28
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003233 subjects
FG004478 subjects
FG005237 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003227 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Withdrawal and Re-treatment: Week 28-72
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG006227 subjects
FG007470 subjects
FG008220 subjects
FG0098 subjects
FG0100 subjects
Nonresponders
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Responders at Week 28
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Responders at Week 28 and Withdrawn From Treatment
These participants were re-treated with guselkumab at or before Week 72.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open-label Guselkumab: Week 72-264
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008211 subjects
FG0090 subjects
FG010656 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
BG001
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
BG002
Adalimumab
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and thereafter through week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000248
BG001496
BG002248
BG003992
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0005
BG0013
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.3± 12.38
BG00143.7± 12.23
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00075
BG001147
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Australia
Title
Measurements
BG00013
BG00125
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 Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group 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).
Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
OG001
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Units
Counts
Participants
OG000248
OG001496
Title
Denominators
Categories
Title
Measurements
OG0008.5
OG00184.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Primary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
OG001
Guselkumab 100 mg
Secondary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
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).
Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
OG001
Adalimumab
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
Secondary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
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).
Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
OG001
Adalimumab
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
Secondary
Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.
Randomized analysis set included all participants who were randomized at Week 0 and who achieved a PASI 90 response at Week 28, were re-randomized to continue guselkumab or receive placebo and with at least one PASI assessment post Week 28.
Posted
Number
Percentage of Participants
Through Week 48
ID
Title
Description
OG000
Withdrawal Group
Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 48 until loss of >=50% in the improvement in PASI.
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
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.
Randomized analysis set included all participants who were randomized at Week 0 and with a baseline DLQI score. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
OG001
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Secondary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group 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).
Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
OG001
Adalimumab
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
OG001
Adalimumab
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
OG001
Adalimumab
Secondary
Percentage of Participants Who Achieved 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 in the Guselkumab Group Compared to the Placebo Group
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.
Population analyzed included only randomized participants who had an ss-IGA score greater than or equal to (>=) 2 at baseline. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
OG001
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.
Secondary
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.
Secondary
Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and1 2, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
OG001
Adalimumab
Secondary
Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.
Population analyzed included PASI 90 responders at Week 28 and who were randomized at Week 28 and treated with guselkumab. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Through Week 72
ID
Title
Description
OG000
Withdrawal Group
Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 72 until loss of >=50% in the improvement in PASI.
Secondary
Percentage of Participants Who Achieved PASI 90 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
OG001
Secondary
Percentage of Participants Who Achieved PASI 75 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, 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 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
OG001
Secondary
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
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). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
OG001
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
Secondary
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
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. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score >1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
Secondary
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score >0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
Secondary
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score >0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
Time Frame
Baseline (Week 0) up to Week 264
Description
Safety analysis: all participants who were randomized at Week 0, received >=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
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 (Week 0 - 16)
Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).
3
248
60
248
EG001
Guselkumab 100 mg (Week 0 - 16)
Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.
8
494
125
494
EG002
Adalimumab (Week 0 - 16)
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.
6
248
51
248
EG003
Placebo Then Guselkumab 100 mg (Week 16 - 28)
Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).
5
233
33
233
EG004
Guselkumab 100 mg (Week 16 - 28)
Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.
10
481
63
481
EG005
Adalimumab (Week 16 - 28)
Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
3
240
45
240
EG006
Placebo Then Guselkumab 100 mg (Week 28 - 264)
Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
36
229
144
229
EG007
Guselkumab 100 mg (Week 28 - 264)
Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
66
473
297
473
EG008
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 36 and q8w through Week 72. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252. The presentation of data from the adalimumab group from Week 28 to Week 264 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 264) and adalimumab (After ACP) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).
36
220
159
220
EG009
Adalimumab (After ACP)
Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of >=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.
1
11
4
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG0031 affected233 at risk
EG0040 affected481 at risk
EG0050 affected240 at risk
EG0061 affected229 at risk
EG0071 affected473 at risk
EG0080 affected220 at risk
EG0090 affected11 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Retinal Vein Occlusion
Eye disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Duodenal Perforation
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Irritable Bowel Syndrome
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Mallory-Weiss Syndrome
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Submaxillary Gland Enlargement
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Sudden Death
General disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Appendicitis Perforated
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Chronic Sinusitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Chronic Tonsillitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Disseminated Tuberculosis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Hiv Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Injection Site Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Peritonsillar Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pilonidal Cyst
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Retroperitoneal Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Soft Tissue Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Vestibular Neuronitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Wound Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Chest Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Eye Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Multiple Fractures
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Nerve Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Spinal Cord Injury Cervical
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Subdural Haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Ulnar Nerve Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Benign Neoplasm of Thyroid Gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Bronchial Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Endometrial Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Ependymoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Fibroadenoma of Breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Inflammatory Pseudotumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Osteochondroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pancreatic Carcinoma Stage Iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Rectal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Sinonasal Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Cerebellar Stroke
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Diabetic Coma
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Myelitis Transverse
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Peripheral Nerve Lesion
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Peripheral Nerve Paresis
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Device Dislocation
Product Issues
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Alcoholism
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0021 affected248 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0020 affected248 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Uterine Haemorrhage
Reproductive system and breast disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Nasal Septum Deviation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Sinus Polyp
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Sleep Apnoea Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Miscarriage of Partner
Social circumstances
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Varicose Vein
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac Failure Congestive
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0010 affected494 at risk
EG0020 affected248 at risk
EG0030 affected233 at risk
EG0040 affected481 at risk
EG0050 affected240 at risk
EG0060 affected229 at risk
EG0070 affected473 at risk
EG0080 affected220 at risk
EG0091 affected11 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected248 at risk
EG00111 affected494 at risk
EG0024 affected248 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected248 at risk
EG0011 affected494 at risk
EG0021 affected248 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0003 affected248 at risk
EG0013 affected494 at risk
EG0025 affected248 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected248 at risk
EG0014 affected494 at risk
EG0025 affected248 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG00016 affected248 at risk
EG00135 affected494 at risk
EG00220 affected248 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected248 at risk
EG0017 affected494 at risk
EG0021 affected248 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0003 affected248 at risk
EG0013 affected494 at risk
EG0022 affected248 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG00010 affected248 at risk
EG00116 affected494 at risk
EG0024 affected248 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected248 at risk
EG0016 affected494 at risk
EG0020 affected248 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected248 at risk
EG0012 affected494 at risk
EG0021 affected248 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0006 affected248 at risk
EG00111 affected494 at risk
EG0022 affected248 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0006 affected248 at risk
EG0014 affected494 at risk
EG0020 affected248 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0007 affected248 at risk
EG00125 affected494 at risk
EG0025 affected248 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0004 affected248 at risk
EG0018 affected494 at risk
EG0021 affected248 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected248 at risk
EG0014 affected494 at risk
EG0021 affected248 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0003 affected248 at risk
EG0011 affected494 at risk
EG0025 affected248 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0004 affected248 at risk
EG00110 affected494 at risk
EG0026 affected248 at risk
EG003
All participants were on guselkumab after Week 76; therefore, there was no concurrent control group within the study after Week 76.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 in writing, such publication will be withheld for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000588857
guselkumab
D000068879
Adalimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
470 subjects
FG005228 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
8 subjects
FG0059 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0043 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0043 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG00680 subjects
FG00795 subjects
FG008112 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG007375 subjectsParticipants randomized to withdrawal=182 and maintenance= 193
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG006147 subjects
FG0070 subjects
FG008108 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG006213 subjects
FG007443 subjects
FG008211 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG00614 subjects
FG00727 subjects
FG0089 subjects
FG0098 subjects
FG0100 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0075 subjects
FG0083 subjects
FG0092 subjects
FG0100 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0073 subjects
FG0082 subjects
FG0092 subjects
FG0100 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0077 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0077 subjects
FG0082 subjects
FG0092 subjects
FG0100 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
Noncompliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Participants not retreated with guselkumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0068 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008173 subjects
FG0090 subjects
FG010554 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00838 subjects
FG0090 subjects
FG010102 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00810 subjects
FG0090 subjects
FG01030 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0103 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
FG0090 subjects
FG01026 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00812 subjects
FG0090 subjects
FG01021 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0088 subjects
FG0090 subjects
FG01019 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
8
Between 18 and 65 years
BG000234
BG001470
BG002237
BG003941
>=65 years
BG0009
BG00123
BG00211
BG00343
43.2
± 11.92
BG00343.5± 12.18
78
BG003300
Male
BG000173
BG001349
BG002170
BG003692
13
BG00351
Czech Republic
Title
Measurements
BG0009
BG00114
BG0028
BG00331
Poland
Title
Measurements
BG00068
BG001133
BG00264
BG003265
Russia
Title
Measurements
BG00024
BG00151
BG00225
BG003100
Canada
Title
Measurements
BG00030
BG00167
BG00233
BG003130
United States
Title
Measurements
BG00049
BG00193
BG00248
BG003190
Germany
Title
Measurements
BG00022
BG00140
BG00222
BG00384
Spain
Title
Measurements
BG00010
BG00122
BG00211
BG00343
Korea, Democratic People'S Republic Of
Title
Measurements
BG00023
BG00151
BG00224
BG00398
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Units
Counts
Participants
OG000248
OG001496
Title
Denominators
Categories
Title
Measurements
OG0002.4
OG00170.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000496
OG001248
Title
Denominators
Categories
Title
Measurements
OG00051.8
OG00131.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000496
OG001248
Title
Denominators
Categories
Title
Measurements
OG00083.5
OG00164.9
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
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG001
Adalimumab
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.
Units
Counts
Participants
OG000496
OG001248
Title
Denominators
Categories
Title
Measurements
OG00075.2
OG00154.8
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
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG001
Guselkumab Maintenance Group
Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48.
Units
Counts
Participants
OG000181
OG001193
Title
Denominators
Categories
Title
Measurements
OG00035.4
OG00181.8
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
p value is based on the log-rank test stratified by investigator site (pooled).
Log Rank
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000248
OG001495
Title
Denominators
Categories
Title
Measurements
OG000-2.6± 6.85
OG001-11.23± 6.82
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
p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).
ANOVA
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000496
OG001248
Title
Denominators
Categories
Title
Measurements
OG00084.1
OG00167.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).
MH Z-test
< 0.001
Difference in Percentage
16.4
2-Sided
95
10.0
23.2
Non-Inferiority or Equivalence (legacy)
non-inferiority margin= -10.0%
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
Units
Counts
Participants
OG000496
OG001248
Title
Denominators
Categories
Title
Measurements
OG00070.0
OG00146.8
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
p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).
MH Z-test
< 0.001
Difference in Percentage
23.3
2-Sided
95
16.0
30.4
Non-Inferiority or Equivalence (legacy)
non-inferiority margin= -10.0%
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
Units
Counts
Participants
OG000496
OG001248
Title
Denominators
Categories
Title
Measurements
OG00086.3
OG00168.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).
MH Z-test
< 0.001
Difference in percentage
17.7
2-Sided
95
11.4
24.4
Non-Inferiority or Equivalence (legacy)
non-inferiority margin= -10%
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000202
OG001408
Title
Denominators
Categories
Title
Measurements
OG00010.9
OG00180.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG001
Guselkumab 100 mg
Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Units
Counts
Participants
OG000198
OG001411
Title
Denominators
Categories
Title
Measurements
OG000-8.3± 23.67
OG001-40.4± 26.52
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
p value is based on ANOVA model stratified by investigator site (pooled).
ANOVA
< 0.001
Superiority or Other (legacy)
Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.
Units
Counts
Participants
OG000410
OG001200
Title
Denominators
Categories
Title
Measurements
OG00035.1
OG00122.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG001
Guselkumab Maintenance Group
Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32, 40 and thereafter through Week 72.
Units
Counts
Participants
OG000181
OG001193
Title
Denominators
Categories
Title
Measurements
OG00011.5
OG00186
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
Units
Counts
Participants
OG000560
OG001177
Title
Denominators
Categories
Title
Measurements
OG00082.0
OG00179.1
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
Units
Counts
Participants
OG000560
OG001177
Title
Denominators
Categories
Title
Measurements
OG00093.4
OG00192.7
Units
Counts
Participants
OG000559
OG001177
Title
Denominators
Categories
Title
Measurements
OG00085.0
OG00183.1
OG001
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
Units
Counts
Participants
OG000550
OG001173
Title
Denominators
Categories
Title
Measurements
OG00071.1
OG00169.9
OG001
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.
Units
Counts
Participants
OG000460
OG001145
Title
Denominators
Categories
Title
Measurements
OG00042.0
OG00136.6
OG001
Adalimumab Then Guselkumab 100 mg (Week 28 - 264)
Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of >=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.