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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03451851
Registration number
NCT03451851
Ethics application status
Date submitted
26/02/2018
Date registered
2/03/2018
Date last updated
23/05/2024
Titles & IDs
Public title
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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Scientific 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)
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Secondary ID [1]
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0
2017-003053-42
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Secondary ID [2]
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0
CR108452
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Universal Trial Number (UTN)
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Trial acronym
PROTOSTAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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0
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo for guselkumab
Treatment: Drugs - Etanercept
Experimental: Part 1 Group 1: Guselkumab - 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.
Placebo Comparator: Part 1 Group 2: Placebo for Guselkumab - 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.
Active Comparator: Part 1 Group 3: Etanercept - 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.
Experimental: Part 2: Guselkumab - 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.
Treatment: Drugs: Guselkumab
Participants will receive a weight-based dose of guselkumab subcutaneously.
Treatment: Drugs: Placebo for guselkumab
Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
Treatment: Drugs: Etanercept
Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response
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Assessment method [2]
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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.
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Timepoint [2]
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Week 16
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Secondary outcome [1]
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Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response
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Assessment method [1]
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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.
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Timepoint [1]
0
0
Week 16
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Secondary outcome [2]
0
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Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0)
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Assessment method [2]
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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.
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Timepoint [2]
0
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Week 16
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Secondary outcome [3]
0
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Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 16 (Part 1) and up to Week 52 (Part 2)
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Secondary outcome [4]
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Part 1: Percentage of Participants who Achieve PASI 100 Response
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Assessment method [4]
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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).
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Timepoint [4]
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Week 16
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Secondary outcome [5]
0
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Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment
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Assessment method [5]
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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.
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Timepoint [5]
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Every 4 weeks after retreatment is initiated, until Week 52
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Secondary outcome [6]
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Part 1: Percentage of Retreated Participants who Achieve PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
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Assessment method [6]
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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.
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Timepoint [6]
0
0
Every 4 weeks after retreatment is initiated, until Week 52
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
0
0
Every 4 weeks after retreatment is initiated, until Week 52
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Secondary outcome [8]
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Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal
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Assessment method [8]
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0
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.
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Timepoint [8]
0
0
Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [9]
0
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Part 1: Time to Loss of PASI 90 Response After Withdrawal
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Assessment method [9]
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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.
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Timepoint [9]
0
0
Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [10]
0
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Part 1: Percentage of Participants who Achieve a PASI 50 Response
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Assessment method [10]
0
0
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.
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Timepoint [10]
0
0
Week 16
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Secondary outcome [11]
0
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Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 2)
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Assessment method [11]
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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.
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Timepoint [11]
0
0
Week 16
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Secondary outcome [12]
0
0
Part 1 and 2: Percent Change From Baseline in PASI Over Time
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Assessment method [12]
0
0
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.
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Timepoint [12]
0
0
Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2)
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Secondary outcome [13]
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Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time
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Assessment method [13]
0
0
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.
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Timepoint [13]
0
0
Up to Week 16 (Part 1); up to Week 52 (Part 2)
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Secondary outcome [14]
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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
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Assessment method [14]
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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.
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Timepoint [14]
0
0
Up to Week 16 (Part 1); up to Week 52 (Part 2)
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Secondary outcome [15]
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Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1
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Assessment method [15]
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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.
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Timepoint [15]
0
0
At Week 16 (Part 1); up to Week 52 (Part 2)
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Secondary outcome [16]
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Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1
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Assessment method [16]
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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.
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Timepoint [16]
0
0
At Week 16 (Part 1); up to Week 52 (Part 2)
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Secondary outcome [17]
0
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Part 1 and 2: Change From Baseline in FDLQI Score
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Assessment method [17]
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0
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.
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Timepoint [17]
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0
Baseline, Week 16 (Part 1); up to Week 52 (Part 2)
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Eligibility
Key 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
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Minimum age
6
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
18/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Eastern Health Research - Box Hill
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Recruitment hospital [2]
0
0
Royal North Shore Hospital - St Leonards
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Recruitment hospital [3]
0
0
Veracity Clinical Research - Woolloongabba
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Recruitment postcode(s) [1]
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0
3128 - Box Hill
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Recruitment postcode(s) [2]
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0
2065 - St Leonards
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Recruitment postcode(s) [3]
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0
4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Georgia
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New Jersey
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Ohio
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Brussels
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Country [9]
0
0
Belgium
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State/province [9]
0
0
Gent
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Liege
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Country [11]
0
0
Canada
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State/province [11]
0
0
Alberta
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Country [12]
0
0
Canada
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State/province [12]
0
0
British Columbia
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Country [13]
0
0
Germany
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State/province [13]
0
0
Bonn
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Country [14]
0
0
Germany
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State/province [14]
0
0
Dresden
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Country [15]
0
0
Germany
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State/province [15]
0
0
Frankfurt
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Country [16]
0
0
Germany
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State/province [16]
0
0
Kiel
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Country [17]
0
0
Germany
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State/province [17]
0
0
Langenau
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Country [18]
0
0
Germany
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State/province [18]
0
0
Selters
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Country [19]
0
0
Germany
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State/province [19]
0
0
Stuttgart
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Miskolc
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Hungary
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Szeged
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Italy
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Ancona
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Italy
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Bologna
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Italy
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Cagliari
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Italy
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Padova
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Italy
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Reggio Emilia
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Netherlands
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Nijmegen
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Poland
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03451851
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03451851
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