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

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)

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 Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Guselkumab; Drug: Placebo for guselkumab; Drug: Etanercept

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Eastern Health Research
  • St Leonards, Australia, 2065
    • Royal North Shore Hospital
  • Woolloongabba, Australia, 4102
    • Veracity Clinical Research
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc.
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Reseach Inc.
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Skin Care Centre
• Germany
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carcus Dresden
  • Frankfurt, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein Kiel
  • Langenau, Germany, 89129
    • Praxis Dr. med. Beate Schwarz - Germany
  • Selters, Germany, 56242
    • Company for Medical Study & Service Selters
  • Stuttgart, Germany, 70178
    • Hautarztpraxis Dr. Leitz & Kollegen
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
• Italy
  • Ancona, Italy, 60026
    • Ospedali Riuniti di Ancona
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Policlinico S. Orsola-Malpighi
  • Cagliari, Italy, 09124
    • AOU di Cagliari
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova - IRCCS
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Medical Center
• Poland
  • Lodz, Poland, 90 265
    • Dermed Centrum Medyczne Sp z o o
  • Warszawa, Poland, 03-924
    • Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
  • Wroclaw, Poland, 50-368
    • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
• United States
  • California
    • Palo Alto, California, United States, 94306
      • Stanford University
    • San Diego, California, United States, 92123
      • University of California, San Diego
  • Georgia
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • New Jersey
    • East Windsor, New Jersey, United States, 08520-2505
      • Windsor Dermatology
  • New York
    • New York, New York, United States, 10003
      • Mt. Sinai School of Medicine
  • Ohio
    • Dayton, Ohio, United States, 45324
      • Wright State Physicians Health Center
  • Texas
    • Arlington, Texas, United States, 76011-3800
      • Arlington Center for Dermatology
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Guselkumab; Participants will receive a weight-based dose of guselkumab subcutaneously.; Other Names: CNTO1959; Drug: Placebo for guselkumab; Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
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.	Drug: Guselkumab; Participants will receive a weight-based dose of guselkumab subcutaneously.; Other Names: CNTO1959; Drug: Placebo for guselkumab; Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
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.	Drug: Guselkumab; Participants will receive a weight-based dose of guselkumab subcutaneously.; Other Names: CNTO1959; Drug: Etanercept; Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.; Other Names: Enbrel
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.	Drug: Guselkumab; Participants will receive a weight-based dose of guselkumab subcutaneously.; Other Names: CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16
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.	Week 16
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.	Baseline, Week 16 (Part 1) and up to Week 52 (Part 2)
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).	Week 16
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.	Every 4 weeks after retreatment is initiated, until Week 52
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.	Every 4 weeks after retreatment is initiated, until Week 52
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.	Every 4 weeks after retreatment is initiated, until Week 52
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.	Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
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.	Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
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.	Week 16
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.	Week 16
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.	Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2)
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.	Up to Week 16 (Part 1); up to Week 52 (Part 2)
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.	Up to Week 16 (Part 1); up to Week 52 (Part 2)
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.	At Week 16 (Part 1); up to Week 52 (Part 2)
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.	At Week 16 (Part 1); up to Week 52 (Part 2)
Part 1 and 2: Change From Baseline in FDLQI Score	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.	Baseline, Week 16 (Part 1); up to Week 52 (Part 2)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): July 19, 2023
• Study Completion (Estimated): December 18, 2026

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept; Antibodies, Monoclonal
• Other Study ID Numbers: CR108452; 2017-003053-42 (EudraCT Number); CNTO1959PSO3011 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No