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Psoriasis drug stelara under safety watch in kids

NCT ID NCT03218488

Disease control Sponsor: Janssen-Cilag International NV 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study follows 135 children aged 6 to 17 with moderate to severe plaque psoriasis who are already starting or have recently started treatment with ustekinumab (Stelara). Researchers are monitoring for serious side effects like infections, cancer, and autoimmune issues, as well as effects on growth and puberty. The goal is to understand the long-term safety of this drug in young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ustekinumab (Stelara)
What this could lead to
If successful, this study could confirm that ustekinumab is safe for long-term use in children with psoriasis, helping doctors manage the disease more confidently.
What could go wrong
This is an observational study, not a treatment trial, so it won't test if the drug works better than other options. It only tracks safety, and results may not apply to all children.

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.

Participants

135 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Aug 2032

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.

Who is studied

The study population consists of pediatric participants (6 years to 17 years of age at the time of inclusion) with a diagnosis of moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice.

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 confirmed diagnosis of moderate to severe chronic plaque psoriasis * Either start therapy with ustekinumab for the treatment of psoriasis within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study; a. the treatment decision must have been taken independently of and prior to a participant's inclusion in the study; b. where participants have started therapy with ustekinumab before the first assessment in the study, appropriate baseline data at the start of ustekinumab treatment must be documented, including psoriasis area and severity index (PASI), physician global assessment of disease (PGA), body surface area (BSA) and children's dermatology life quality index (CDLQI) scores where available * Participants (and/or a legally-acceptable representative/guardian where applicable) must sign a participation agreement/informed consent form (ICF) allowing source data collection and verification in accordance with local requirements and the participants (and/or a legally-acceptable representative/guardian where applicable) must be able to understand and complete the requested patient-reported outcomes (PROs) * Be willing to participate in the study Exclusion Criteria: * Is enrolled in an interventional clinical study

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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

  • Andreas Sygros Hospital

    Athens, 16121, Greece

  • Bispebjerg Hospital

    Copenhagen, NV 2400, Denmark

  • CH Victor Dupouy Argenteuil

    Argenteuil, 95107, France

  • CHRU Besancon Hopital Jean Minjoz

    Besançon, 25030, France

  • CHU Saint Etienne Hopital Nord

    Saint-Etienne, 42055, France

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000, Belgium

  • FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences

    Moscow, 119991, Russia

  • Gemeinschaftspraxis Dres. Quist

    Mainz, 55128, Germany

  • Gentofte Herlev Hospital

    Hellerup, 2800, Denmark

  • Grand Hôpital de Charleroi

    Loverval, 6280, Belgium

  • Great Ormond Street Hospital

    London, WC1N 3JH, United Kingdom

  • Groupe Hospitalier Pellegrin CHU de Bordeaux

    Bordeaux, 33076, France

  • Hopital Necker Enfants Malades

    Paris, 75743, France

  • ICH Hopital A. Morvan

    Brest, 29609, France

  • Kinderspital Zürich

    Zurich, 8032, Switzerland

  • Le Bateau Blanc

    Martigues, 13500, France

  • Llc Ultramed

    Omsk, 644024, Russia

  • Moscow Research-Practical Center of Dermatovenerology and Cosmetology

    Moscow, 119049, Russia

  • Oslo universitetssykehus HF, Rikshospitalet

    Oslo, 0027, Norway

  • Praxis Dr. med. Beate Schwarz - Germany

    Langenau, 89129, Germany

  • Radboudumc

    Nijmegen, 6525 EX, Netherlands

  • Saint-Petersburg State Pediatric Medical Academy of RosZdrav

    Saint Petersburg, 194353, Russia

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • UCL Hopital Saint-Luc

    Brussels, 1200, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uniklinik Graz

    Graz, 8036, Austria

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131, Germany

  • University Hospital for Skin and Venereal Diseases

    Thessaloniki, 54 643, Greece

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • Whipps Cross University Hospital

    London, E11 1NR, United Kingdom

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