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

Primary Purpose

Psoriasis

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Guselkumab

Placebo for guselkumab

Etanercept

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford UniversityRecruiting
University of California, San DiegoRecruiting
Dermatologic Surgery Specialists
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's HospitalRecruiting
Arlington DermatologyRecruiting
Windsor Dermatology
Mt. Sinai School of Medicine
Wright State Physicians Health CenterRecruiting
Arlington Center for DermatologyRecruiting
Dell Children's Medical Center of Central TexasRecruiting
Eastern Health Research
Royal North Shore Hospital
Veracity Clinical Research
Cliniques Universitaires Saint-Luc
Universitair Ziekenhuis Gent
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Kirk Barber Reseach Inc.
Dermatology Research Institute Inc.
Skin Care Centre
Universitatsklinikum Bonn
Universitatsklinikum Carl Gustav Carcus Dresden
Universitatsklinikum Frankfurt
Universitatsklinikum Schleswig-Holstein - Kiel
Praxis Dr. med. Beate Schwarz - Germany
Company for Medical Study & Service Selters
Hautarztpraxis Dr. Leitz & Kollegen
Obudai Egeszsegugyi Centrum Kft.
Debreceni Egyetem
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Szegedi Tudomanyegyetem
Ospedali Riuniti Di AnconaRecruiting
Azienda Ospedaliera Policlinico S. Orsola-MalpighiRecruiting
AOU di CagliariRecruiting
Azienda Ospedaliera di PadovaRecruiting
Arcispedale Santa Maria Nuova - IRCCSRecruiting
Radboud University Medical Center
Dermed Centrum Medyczne Sp. z o.oRecruiting
Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w WarszawieRecruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

Part 1 Group 1: Guselkumab

Part 1 Group 2: Placebo for Guselkumab

Part 1 Group 3: Etanercept

Part 2: Guselkumab

Arm Description

Participants in Part 1a (age greater than or equal to (>=) 12 - less than (<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose >=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.

Participants in Part 1a (age >= 12 - <18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose >=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.

Participants in Part 1a (age >= 12 - <18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age >= 6 - <12 years) will follow the same dosing and commence after Part 1a data review.

Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter.

Outcomes

Primary Outcome Measures

Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas are 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 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 75 response represents at least a 75% improvement from baseline in the PASI score.

Secondary Outcome Measures

Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.

Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0)

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)

The CDLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4-item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater the impairment in QoL.

Part 1: Percentage of Participants who Achieve PASI 100 Response

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 100 response represents 100% improvement from baseline in the PASI score (i.e., a PASI score of 0).

Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment

Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.

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

Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90 and 100 response represents at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.

Part 1: Percentage of Retreated Participants who Achieve 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

Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, these participants will be retreated with guselkumab. The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal

Loss of 50% of PASI improvement is defined as a loss of >=50% of the improvement in PASI at Week 16 after treatment is withdrawn. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Part 1: Time to Loss of PASI 90 Response After Withdrawal

Loss of PASI 90 Response is defined as <90% improvement in PASI from baseline after Week 16 in a participant who had achieved >=90% improvement in PASI from baseline at Week 16. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.

Part 1: Percentage of Participants who Achieve a PASI 50 Response

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 50 response represents at least a 50% improvement from baseline in the PASI score.

Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 2)

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Part 1 and 2: Percent Change From Baseline in PASI Over Time

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90, and 100 responses represents at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.

Part 1 and 2: Percentage of Participants with 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

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1

The CDLQI is a dermatology-specific QoL instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4 item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in QoL.

Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1

The FDLQI is 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. Each item has 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 ranges from 0 to 30; a higher score indicates greater impairment of QoL. This instrument should be completed by a participant's primary care-giver.

Part 1 and 2: Change From Baseline in FDLQI Score

Full Information

NCT ID

NCT03451851

First Posted

February 26, 2018

Last Updated

October 10, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03451851

Brief Title

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

Acronym

PROTOSTAR

Official Title

A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 11, 2018 (Actual)

Primary Completion Date

July 19, 2023 (Actual)

Study Completion Date

June 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1 Group 1: Guselkumab

Arm Type

Experimental

Arm Description

Arm Title

Part 1 Group 2: Placebo for Guselkumab

Arm Type

Placebo Comparator

Arm Description

Arm Title

Part 1 Group 3: Etanercept

Arm Type

Active Comparator

Arm Description

Arm Title

Part 2: Guselkumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Guselkumab

Other Intervention Name(s)

CNTO1959

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo for guselkumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etanercept

Other Intervention Name(s)

Enbrel

Intervention Description

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

Primary Outcome Measure Information:

Title

Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)

Description

Time Frame

Week 16

Title

Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response

Description

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.

Time Frame

Week 16

Title

Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0)

Description

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Time Frame

Week 16

Title

Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)

Description

Time Frame

Baseline, Week 16 (Part 1) and up to Week 52 (Part 2)

Title

Part 1: Percentage of Participants who Achieve PASI 100 Response

Description

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 100 response represents 100% improvement from baseline in the PASI score (i.e., a PASI score of 0).

Time Frame

Week 16

Title

Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment

Description

Time Frame

Every 4 weeks after retreatment is initiated, until Week 52

Title

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

Description

Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90 and 100 response represents at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.

Time Frame

Every 4 weeks after retreatment is initiated, until Week 52

Title

Description

Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of >=50% of the improvement in PASI achieved at Week 16, these participants will be retreated with guselkumab. The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Time Frame

Every 4 weeks after retreatment is initiated, until Week 52

Title

Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal

Description

Time Frame

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

Title

Part 1: Time to Loss of PASI 90 Response After Withdrawal

Description

Time Frame

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

Title

Part 1: Percentage of Participants who Achieve a PASI 50 Response

Description

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 50 response represents at least a 50% improvement from baseline in the PASI score.

Time Frame

Week 16

Title

Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 2)

Description

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Time Frame

Week 16

Title

Part 1 and 2: Percent Change From Baseline in PASI Over Time

Description

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Time Frame

Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2)

Title

Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time

Description

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas 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 produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90, and 100 responses represents at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.

Time Frame

Up to Week 16 (Part 1); up to Week 52 (Part 2)

Title

Part 1 and 2: Percentage of Participants with 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

Description

The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.

Time Frame

Up to Week 16 (Part 1); up to Week 52 (Part 2)

Title

Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1

Description

Time Frame

At Week 16 (Part 1); up to Week 52 (Part 2)

Title

Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1

Description

Time Frame

At Week 16 (Part 1); up to Week 52 (Part 2)

Title

Part 1 and 2: Change From Baseline in FDLQI Score

Description

Time Frame

Baseline, Week 16 (Part 1); up to Week 52 (Part 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Contact

Phone

844-434-4210

Participate-In-This-Study@its.jnj.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94306

Country

United States

Individual Site Status

Recruiting

Facility Name

University of California, San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Individual Site Status

Recruiting

Facility Name

Dermatologic Surgery Specialists

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Individual Site Status

Completed

Facility Name

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

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Name

Arlington Dermatology

City

Rolling Meadows

State/Province

Illinois

ZIP/Postal Code

60008

Country

United States

Individual Site Status

Recruiting

Facility Name

Windsor Dermatology

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520-2505

Country

United States

Individual Site Status

Completed

Facility Name

Mt. Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Individual Site Status

Completed

Facility Name

Wright State Physicians Health Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Individual Site Status

Recruiting

Facility Name

Arlington Center for Dermatology

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011-3800

Country

United States

Individual Site Status

Recruiting

Facility Name

Dell Children's Medical Center of Central Texas

City

Austin

State/Province

Texas

ZIP/Postal Code

78723

Country

United States

Individual Site Status

Recruiting

Facility Name

Eastern Health Research

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Individual Site Status

Completed

Facility Name

Royal North Shore Hospital

City

St Leonards

ZIP/Postal Code

2065

Country

Australia

Individual Site Status

Completed

Facility Name

Veracity Clinical Research

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Individual Site Status

Completed

Facility Name

Cliniques Universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Kirk Barber Reseach Inc.

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Dermatology Research Institute Inc.

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2J 7E1

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Skin Care Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E8

Country

Canada

Individual Site Status

Completed

Facility Name

Universitatsklinikum Bonn

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Universitatsklinikum Carl Gustav Carcus Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Universitatsklinikum Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Completed

Facility Name

Universitatsklinikum Schleswig-Holstein - Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Individual Site Status

Completed

Facility Name

Praxis Dr. med. Beate Schwarz - Germany

City

Langenau

ZIP/Postal Code

89129

Country

Germany

Individual Site Status

Completed

Facility Name

Company for Medical Study & Service Selters

City

Selters

ZIP/Postal Code

56242

Country

Germany

Individual Site Status

Completed

Facility Name

Hautarztpraxis Dr. Leitz & Kollegen

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Obudai Egeszsegugyi Centrum Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Debreceni Egyetem

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Szegedi Tudomanyegyetem

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Individual Site Status

Completed

Facility Name

Ospedali Riuniti Di Ancona

City

Ancona

ZIP/Postal Code

60026

Country

Italy

Individual Site Status

Recruiting

Facility Name

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Name

AOU di Cagliari

City

Cagliari

ZIP/Postal Code

09124

Country

Italy

Individual Site Status

Recruiting

Facility Name

Azienda Ospedaliera di Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Individual Site Status

Recruiting

Facility Name

Arcispedale Santa Maria Nuova - IRCCS

City

Reggio Emilia

ZIP/Postal Code

42123

Country

Italy

Individual Site Status

Recruiting

Facility Name

Radboud University Medical Center

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Individual Site Status

Completed

Facility Name

Dermed Centrum Medyczne Sp. z o.o

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Individual Site Status

Recruiting

Facility Name

Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie

City

Warszawa

ZIP/Postal Code

03-924

Country

Poland

Individual Site Status

Recruiting

Facility Name

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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