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NCT03451851Active, not recruitingPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
120 (actual)
First submitted
26 Feb 2018
Start date
11 Jul 2018
Primary completion date
19 Jul 2023
Lead sponsor
Janssen Research & Development, LLC
Diseases
Psoriasis
NCT number
NCT03451851
EU CT number
2023-503378-19-00
EudraCT number
2017-003053-42

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 120
  • From 11 Jul 2018 to the primary completion date, 19 Jul 2023
  • 32 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has previously received guselkumab or etanercept

Other illness

  • 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

Lab values

  • Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

Other

  • Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)

Who the study is looking for

  • 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

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Eastern Health Research
Coordinator of this site? Confirm its status
Box HillAustraliaUnknown status
Royal North Shore Hospital
Coordinator of this site? Confirm its status
St LeonardsAustraliaUnknown status
Veracity Clinical Research
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumActive, not recruiting
CHU de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Dermatology Research Institute Inc
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Kirk Barber Reseach Inc.
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Skin Care Centre
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Universitaetsklinikum Bonn AöR
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BonnGermanyActive, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Coordinator of this site? Confirm its status
DresdenGermanyActive, not recruiting
Hautarztpraxis Dr. Leitz Und Kollegen
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StuttgartGermanyActive, not recruiting
Obudai Egeszsegugyi Centrum Kft.
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Budapest IIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
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MiskolcHungaryActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Azienda Ospedale Universita Padova
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PadovaItalyActive, not recruiting
Radboud University Medical Center
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NijmegenNetherlandsUnknown status
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandActive, not recruiting
Szpital Dzieciecy Im. Prof. Dr Med. Jana Bogdanowicza Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
Arlington Center for Dermatology
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ArlingtonUnited StatesUnknown status
Dell Children's Medical Center of Central Texas
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AustinUnited StatesUnknown status
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Wright State Physicians Health Center
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DaytonUnited StatesUnknown status
Windsor Dermatology
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East WindsorUnited StatesUnknown status
Dermatologic Surgery Specialists
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MaconUnited StatesUnknown status
Mt. Sinai School of Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Stanford University
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Palo AltoUnited StatesUnknown status
Arlington Dermatology
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Rolling MeadowsUnited StatesUnknown status
University of California San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.