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New hope for kids with severe colitis: drug shows promise in major trial

NCT ID NCT04630028

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a drug called ustekinumab in 112 children with moderate-to-severe ulcerative colitis, a condition causing inflammation in the colon. The goal was to see if the drug could reduce symptoms like diarrhea and bleeding and help the colon heal. Children first received the drug through an IV, then as shots to maintain improvement. The study checked for side effects and how well the drug worked over time.

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

Mar 2021

Finished

Jun 2025

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: * Medically stable 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 acknowledged by the investigator * Must have had UC diagnosed prior to screening * Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (\>=) 2 as determined by a central review of the video of the endoscopy * A participant who has had extensive colitis for \>= 8 years, or disease limited to the left side of the colon for \>= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention * Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration Exclusion Criteria: * Have UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon * Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy) * Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening * Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly * Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

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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

  • Birmingham Children's Hospital

    Birmingham, B4 6NH, United Kingdom

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526, Hungary

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Charite-Universitätsmedizin Berlin - Berlin

    Berlin, 13353, Germany

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342, United States

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Dr. von Haunersches Kinderspital

    Munich, 80337, Germany

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

    Moscow, 119991, Russia

  • GASTROMED Sp. z o.o.

    Torun, 87 100, Poland

  • Gunma University Hospital

    Gunma, 371-0034, Japan

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730, Poland

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498, Japan

  • Juntendo University Hospital

    Bunkyō City, 113 8431, Japan

  • KUNO Klinik St. Hedwig

    Regensburg, 93049, Germany

  • Kazan State Medical University

    Kazan', 420138, Russia

  • 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

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Mie University Hospital

    Tsu, 514 8507, Japan

  • Miyagi Children's Hospital

    Sendai, 989-3126, Japan

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962, United States

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535, Japan

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Pediatric Specialists Of Virginia

    Fairfax, Virginia, 22031, United States

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033, United States

  • Privolzhsky Research Medical University of Ministry of Health of Russian Federation

    Nizhny Novgorod, 603950, Russia

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Royal London Hospital

    London, E1 2AT, United Kingdom

  • Russian National Research Medical University named after N.I.Pirogov

    Moscow, 119571, Russia

  • Saitama Childrens Medical Center

    Saitama Shi, 330-8777, Japan

  • Saratov State Medical University

    Saratov, 410054, Russia

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300, Israel

  • Sheba Medical Center

    Ramat Gan, 30700, Israel

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

    Szeged, 6720, Hungary

  • Szpital im. M. Kopernika

    Gdansk, 80 803, Poland

  • UZ Brussel

    Jette, 1090, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels, 1020, Belgium

  • Universitatsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • Universitatsklinikum Ulm

    Ulm, 89075, Germany

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8BJ, United Kingdom

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Universitätsklinikum Aachen

    Aachen, 52074, Germany

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663, Poland

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501, Poland

  • Yaroslavl Regional Children's Clinical Hospital

    Yaroslavl, 150032, Russia

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