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New hope for kids with stubborn psoriasis: drug trial shows promise

NCT ID NCT03451851

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests a drug called guselkumab in children aged 6 to 17 with chronic plaque psoriasis. The goal is to see if it safely clears skin patches better than a placebo or another treatment. About 120 participants will receive injections and be monitored for 16 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

120 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriasis

Contacts and locations

Locations

  • AOU di Cagliari

    Cagliari, 09124, Italy

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123, Italy

  • Arlington Center for Dermatology

    Arlington, Texas, 76011-3800, United States

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008, United States

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliera di Padova

    Padova, 35128, Italy

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526, Hungary

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, 4000, Belgium

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Company for Medical Study & Service Selters

    Selters, 56242, Germany

  • Debreceni Egyetem

    Debrecen, 4032, Hungary

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723, United States

  • Dermatologic Surgery Specialists

    Macon, Georgia, 31217, United States

  • Dermatology Research Institute Inc

    Calgary, Alberta, T2J 7E1, Canada

  • Dermed Centrum Medyczne Sp z o o

    Lodz, 90-265, Poland

  • Eastern Health Research

    Box Hill, 3128, Australia

  • Hautarztpraxis Dr. Leitz & Kollegen

    Stuttgart, 70178, Germany

  • Kirk Barber Reseach Inc.

    Calgary, Alberta, T2G 1B1, Canada

  • Mt. Sinai School of Medicine

    New York, New York, 10003, United States

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

    Chicago, Illinois, 60611, United States

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036, Hungary

  • Ospedali Riuniti Di Ancona

    Ancona, 60026, Italy

  • Praxis Dr. med. Beate Schwarz - Germany

    Langenau, 89129, Germany

  • Radboud University Medical Center

    Nijmegen, 6525 GA, Netherlands

  • Royal North Shore Hospital

    St Leonards, 2065, Australia

  • Skin Care Centre

    Vancouver, British Columbia, V5Z 4E8, Canada

  • Stanford University

    Palo Alto, California, 94306, United States

  • Szegedi Tudomanyegyetem

    Szeged, 6720, Hungary

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

    Warsaw, 03-924, Poland

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsklinikum Bonn

    Bonn, 53127, Germany

  • Universitatsklinikum Carl Gustav Carcus Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105, Germany

  • University of California, San Diego

    San Diego, California, 92123, United States

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 556, Poland

  • Veracity Clinical Research

    Woolloongabba, 4102, Australia

  • Windsor Dermatology

    East Windsor, New Jersey, 08520-2505, United States

  • Wright State Physicians Health Center

    Dayton, Ohio, 45324, United States

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