A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

Phase 3Active Not RecruitingNCT03451851

Janssen Research & Development, LLC120 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Psoriasis

Interventions

GuselkumabDRUG

Participants will receive a weight-based dose of guselkumab subcutaneously.

Placebo for guselkumabDRUG

Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.

EtanerceptDRUG

Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis \[PsA\]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (\>=) 3, Psoriasis Area and Severity Index (PASI) \>=12, \>=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI\>=20, \>20% BSA involvement, or IGA=4 * Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment) * Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy * Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling * Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator * Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention Exclusion Criteria: * Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular) * Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * Has previously received guselkumab or etanercept * Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers * Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

Locations (39)

Outcomes

Primary Outcomes

Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: At Week 16

Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.

Time frame: At Week 16

Secondary Outcomes

Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16

Data from ClinicalTrials.gov

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Stanford University

Palo Alto, California, United States

University of California, San Diego

San Diego, California, United States

Dermatologic Surgery Specialists

Macon, Georgia, United States

Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital

Chicago, Illinois, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Windsor Dermatology

East Windsor, New Jersey, United States

Mt. Sinai School of Medicine

New York, New York, United States

Wright State Physicians Health Center

Dayton, Ohio, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

...and 29 more locations

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: At Week 16

Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16

Time frame: At Week 16

Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.

Time frame: At Week 16

Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16

CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score.

Time frame: Baseline and Week 16

Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment

PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.

Time frame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.

Time frame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16

Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of \>=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.

Time frame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16

Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.

Time frame: Week 20, 24, 28, 32, 36, 40, 44, 48, and 52

Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.

Time frame: At Week 16

Part 1: Percent Improvement From Baseline in PASI Through Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.

Time frame: Weeks 4, 8, 12, and 16

Part 2: Percent Improvement From Baseline in PASI Through Week 52

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.

Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.

Time frame: Weeks 4, 8, 12, and 16

Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.

Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16

Time frame: Weeks 4, 8, 12, and 16

Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52

Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Part 2: Change From Baseline in CDLQI Score Through Week 52

Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: Baseline, Weeks 8, 16, 28, 36, and 52

Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1

CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: At Week 16

Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1

CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: Weeks 8, 16, 28, 36, and 52

Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1

The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.

Time frame: At Week 16

Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1

The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.

Time frame: Weeks 8, 16, 28, 36, and 52

Part 1: Change From Baseline in FDLQI Score at Week 16

The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.

Time frame: Baseline and Week 16

Part 2: Change From Baseline in FDLQI Score Through Week 52

The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.

Time frame: Baseline, Weeks 8, 16, 28, 36, and 52

Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16

Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Time frame: Baseline and Week 16

Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52

Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time

Time frame: From Week 52 to End of the study (EOS) (December 2026)

LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time

Time frame: From Week 52 to EOS (December 2026)

LTE Phase: Percent Improvement From Baseline in PASI Over Time

Time frame: From Week 52 to EOS (December 2026)

LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time

Time frame: From Week 52 to EOS (Dec 2026)

LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52

Time frame: Week 60 and Week 84

LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment

Time frame: Week 60 and Week 84

LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52

Time frame: Week 60 and Week 84

LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52

Time frame: Week 60 and Week 84