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Children with Crohn's, colitis, or psoriatic arthritis get long-term safety check on stelara

NCT ID NCT05092269

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study follows 159 children aged 2 to 17 who have already completed a prior ustekinumab study for Crohn's disease, ulcerative colitis, or psoriatic arthritis. The goal is to collect long-term safety data by monitoring side effects, lab results, and injection-site reactions. Participants receive ustekinumab as a subcutaneous injection, and the study is open-label, meaning everyone knows they are getting the drug.

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 show that ustekinumab is safe for long-term use in children, supporting its continued use to manage these chronic conditions.
What could go wrong
This is an open-label extension study focused on safety, not on proving new benefits. It may not show significant new efficacy data, and side effects like infections or injection reactions remain possible.

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

159 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Mar 2028

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

2 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: * Must have completed the dosing planned in the primary pediatric ustekinumab study * Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study) * Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * Must be willing and able to adhere to the lifestyle restrictions specified in this protocol * Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration Exclusion Criteria: * Are pregnant, nursing, or planning pregnancy or fathering a child * Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 \[COVID-19\]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit * Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 \[COVID-19\]) is not automatically an exclusion criterion and must be discussed with the medical monitor

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Conditions

The condition(s) this trial relates to.

Crohn disease psoriatic arthritis ulcerative colitis

As listed by the trial registrant

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

Arthritis, psoriatic Colitis ulcerative Crohn disease

Contacts and locations

Locations

  • Addenbrookes Hospital

    Cambridge, Cb2 2qq, United Kingdom

  • Birmingham Children's Hospital

    Birmingham, B4 6NH, United Kingdom

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526, Hungary

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o

    Sosnowiec, 41 200, Poland

  • Cerrahpasa Medical Faculty Hospital

    Istanbul, 34098, Turkey (Türkiye)

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353, Germany

  • Children's Center For Digestive Healthcare, Llc

    Atlanta, Georgia, 30342, United States

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122, Italy

  • GASTROMED Sp. z o.o.

    Torun, 87 100, Poland

  • Great Ormond Street Hospital

    London, WC1N 3JH, United Kingdom

  • Gunma University Hospital

    Gunma, 371-0034, Japan

  • Hacettepe University Medical Faculty

    Ankara, 06230, Turkey (Türkiye)

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hospital de Ninos de Cordoba

    Córdoba, X5014FTO, Argentina

  • Huderf

    Brussels, 1020, Belgium

  • Hôpital Necker

    Paris, 75015, France

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730, Poland

  • Juntendo University Hospital

    Bunkyō City, 113 8431, Japan

  • Kindai University Nara Hospital

    Ikoma, 630 0293, Japan

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302, Poland

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Levine Childrens at Atrium Health

    Charlotte, North Carolina, 28207, United States

  • Medical Network

    Warsaw, 04-501, Poland

  • Medical Network 1

    Warsaw, 04-501, Poland

  • Mie University Hospital

    Tsu, 514 8507, Japan

  • Miyagi Childrens Hospital

    Sendai, 989-3126, Japan

  • Mount Sinai

    New York, New York, 10029, United States

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535, Japan

  • Pediatric Specialists Of Virginia

    Fairfax, Virginia, 22031, United States

  • Royal London Hospital

    London, E1 1BB, United Kingdom

  • STAT Research S A

    Buenos Aires, C1060, Argentina

  • Saitama Childrens Medical Center

    Saitama Shi, 330-8777, Japan

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    Ramat Gan, 5266202, Israel

  • Sheffield Children's Hospital

    Sheffield, S10 2TH, United Kingdom

  • Southampton University Hospital

    Southampton, SO16 6YD, United Kingdom

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Szegedi Tudomanyegyetem

    Szeged, 6720, Hungary

  • UZ Brussel

    Jette, 1090, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074, Germany

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663, Poland

  • Uz Gasthuisberg

    Leuven, 3000, Belgium

  • Yitzhak Shamir Medical Center

    Beer Yaakov, 70300, Israel

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