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Kids with gut or joint inflammation get long-term safety check on biologic drug guselkumab

NCT ID NCT06663332

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This study is checking the long-term safety of guselkumab, a biologic drug given as a shot, in children with moderate to severe Crohn's disease, ulcerative colitis, or juvenile psoriatic arthritis. About 196 kids who already completed a prior guselkumab study and benefited from it will continue treatment. The main goal is to track any side effects over time.

What this could mean

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

Active substance
guselkumab (a biologic drug given as a shot under the skin)
What this could lead to
If successful, this study could show that guselkumab is safe for long-term use in children with these inflammatory conditions, offering a treatment option to control disease.
What could go wrong
This is an extension study, so participants already benefited from guselkumab. It is open-label (no placebo), which can bias results. Long-term side effects are still being monitored.

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

About 196 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 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.

Ages

3 years and older

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 guselkumab study * Must have received benefit from continued guselkumab therapy in the opinion of the investigator * Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure * Parent(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 required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate. Exclusion Criteria: * Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication * Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication * Are pregnant, nursing, or planning pregnancy or fathering a child * Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention * Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

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Conditions

The condition(s) this trial relates to.

Crohn disease juvenile idiopathic arthritis psoriasis-related juvenile idiopathic arthritis psoriatic arthritis ulcerative colitis

As listed by the trial registrant

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

Arthritis, juvenile Arthritis, psoriatic Colitis ulcerative Crohns disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII Bergamo

    RECRUITING

    Bergamo, 24127, Italy

  • Akershus Universitetssykehus

    RECRUITING

    Akershus, 1478, Norway

  • Asklepios Klinik Sankt Augustin

    RECRUITING

    Sankt Augustin, 53757, Germany

  • Azienda USL di Bologna - Ospedale Maggiore

    RECRUITING

    Bologna, 40121, Italy

  • Capital Center For Children's health Capital Medical University

    RECRUITING

    Beijing, 100020, China

  • Casa Sollievo Della Sofferenza IRCCS

    RECRUITING

    San Giovanni Rotondo, 71013, Italy

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

    RECRUITING

    Sosnowiec, 41 200, Poland

  • Changzhou No 2 Peoples Hospital

    RECRUITING

    Changzhou, 213003, China

  • Children's Center for Digestive Healthcare

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Gazi University Medical Faculty

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • Haywood Hospital

    RECRUITING

    Stoke-on-Trent, ST6 7AG, United Kingdom

  • Hosp. Clinico Univ. de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hosp. Univ. I Politecni La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Center University De Lille

    RECRUITING

    Lille, 59000, France

  • Hospital das Clinicas - UFG

    RECRUITING

    Goiânia, 74605 020, Brazil

  • INTEGRAL Pesquisa e Ensino

    RECRUITING

    Votuporanga, 15500-269, Brazil

  • IRCCS Materno Infantile Burlo Garofolo

    RECRUITING

    Trieste, 34137, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesu

    RECRUITING

    Roma, 00165, Italy

  • Instituto Caici

    RECRUITING

    Rosario, S2003CVB, Argentina

  • Instytut Pomnik Centrum Zdrowia Dziecka

    RECRUITING

    Warsaw, 04-730, Poland

  • Japanese Red Cross Kumamoto Hospital

    RECRUITING

    Kumamoto, 861 8520, Japan

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, 920 8641, Japan

  • Kobe University Hospital

    RECRUITING

    Kobe, 650 0017, Japan

  • Kocaeli Universitesi Hastanesi

    RECRUITING

    Kocaeli, 41380, Turkey (Türkiye)

  • Korczowski Bartosz Gabinet Lekarski

    RECRUITING

    Rzeszów, 35-302, Poland

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    RECRUITING

    South Brisbane, 4101, Australia

  • Medical Network

    RECRUITING

    Warsaw, 04-501, Poland

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Ruijin Hospital Shanghai Jiao Tong University

    RECRUITING

    Shanghai, 200025, China

  • Saga University Hospital

    RECRUITING

    Saga, 849 0937, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Schon Klinik Hamburg Eilbek

    RECRUITING

    Hamburg, 22081, Germany

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Sheffield Children's Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Shengjing Hospital Of China Medical University

    RECRUITING

    Shenyang, 110055, China

  • Shinshu University Hospital

    RECRUITING

    Matsumoto, 390 8621, Japan

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310016, China

  • The Children's Hospital at Westmead

    RECRUITING

    Westmead, 2145, Australia

  • The Childrens Hospital Zhejiang University School Of Medicine

    RECRUITING

    Hangzhou, 310005, China

  • The Kids Research Institute Australia on behalf of the Centre for Child Health Research

    RECRUITING

    Nedlands, 6009, Australia

  • Tokyo Metropolitan Children's Medical Center

    RECRUITING

    Fuchū, 183 8561, Japan

  • Uls Braga - Hosp. Braga

    RECRUITING

    Braga, 4710 243, Portugal

  • Uls Sao Joao - Hosp. Sao Joao

    RECRUITING

    Porto, 4200 319, Portugal

  • Umraniye Training and Research Hospital

    RECRUITING

    Istanbul, 34764, Turkey (Türkiye)

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, 232 0024, Japan

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Other studies related to the condition(s) this trial covers.