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
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eastern Health Research Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Veracity Clinical Research Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Dermatology Research Institute Inc Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Kirk Barber Reseach Inc. Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Skin Care Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Hautarztpraxis Dr. Leitz Und Kollegen Coordinator of this site? Confirm its status | Stuttgart | Germany | Active, not recruiting |
| Obudai Egeszsegugyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Miskolc | Hungary | Active, not recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Szpital Dzieciecy Im. Prof. Dr Med. Jana Bogdanowicza Samodzielny Publiczny Zaklad Opieki Zdrowotnej Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Arlington Center for Dermatology Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Wright State Physicians Health Center Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Windsor Dermatology Coordinator of this site? Confirm its status | East Windsor | United States | Unknown status |
| Dermatologic Surgery Specialists Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Mt. Sinai School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Arlington Dermatology Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.