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Hope for kids with severe colitis: new drug trial shows promise

NCT ID NCT06260163

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a drug called guselkumab in children aged 2-17 with moderate to severe ulcerative colitis, a condition causing inflammation in the colon. The goal is to see if the drug can bring the disease under control and keep it in remission for up to 56 weeks. About 112 children will receive the drug, and researchers will monitor their symptoms and safety.

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

112 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Apr 2027

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: * Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening * A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC. * Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy * Medically stable based on 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 acknowledged by the investigator * Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids Exclusion Criteria: * Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon * Presence of a stoma * Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline * Have severe colitis or have evidence of Crohn's Disease (CD)

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative

Contacts and locations

Locations

  • AOU Meyer

    Florence, 50139, Italy

  • AOU Policlinico Umberto I

    Roma, 00161, Italy

  • APHP Hopital Robert Debre

    Paris, 75019, France

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127, Italy

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Akershus Universitetssykehus

    Lørenskog, 1478, Norway

  • Ankara University Medical Faculty

    Ankara, 6620, Turkey (Türkiye)

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40133, Italy

  • CHRU Lille

    Lille, 59037, France

  • CHU Charleroi Chimay

    Charleroi, 6042, Belgium

  • CHU Toulouse

    Toulouse, 31059, France

  • Capital Center For Children's health Capital Medical University

    Beijing, 100020, China

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004, China

  • Children's Hospital Oakland

    Oakland, California, 94609, United States

  • Copernicus Podmiot Leczniczy Sp. z o.o

    Gdansk, 80 803, Poland

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08028, Spain

  • Gazi University Medical Faculty

    Ankara, 06560, Turkey (Türkiye)

  • Henan Children's Hospital, Zhengzhou Children's Hospital

    Zhengzhou, 450052, China

  • Hopital Francois Mitterand

    Dijon, 21000, France

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant

    Bron, 69677, France

  • Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730, Poland

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Kobe University Hospital

    Kobe, 650 0017, Japan

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302, Poland

  • Marmara University Pendik Training Hospital

    Istanbul, 34899, Turkey (Türkiye)

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101, Australia

  • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501, Poland

  • NYU Langone Health

    Lake Success, New York, 11042, United States

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686, Japan

  • Oslo University Hospital

    Oslo, 0450, Norway

  • Ospedale S. Spirito, Azienda Sanitaria Pescara

    Pescara, 65124, Italy

  • Peking University Third Hospital

    Beijing, 100191, China

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025, China

  • Saga University Hospital

    Saga, 849-8501, Japan

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 230-8765, Japan

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004, China

  • Shinshu University Hospital

    Matsumoto, 390 8621, Japan

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016, China

  • St. Olavs Hospital

    Trondheim, 7030, Norway

  • The Children's Hospital at Westmead

    Westmead, 2145, Australia

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou, 310005, China

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

    Nedlands, 6009, Australia

  • Tokyo Medical University Hospital

    Shinjuku, 160 0023, Japan

  • Tokyo Metropolitan Children's Medical Center

    Fuchū, 183 8561, Japan

  • UZ Brussel

    Jette, 1090, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649-035, Portugal

  • Uls Santo Antonio - Cmin

    Porto, 4050-651, Portugal

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319, Portugal

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9030, Norway

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