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

NCT ID NCT04630028

Completed Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

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.

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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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