A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Last updated: February 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Guselkumab Intravenous

Guselkumab Subcutaneous

Matching Placebo

Clinical Study ID

NCT06260163
CR109251
CNTO1959PUC3001
2022-502238-22-00
2022-001285-35
  • Ages 2-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent forscreening

  • A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) mustbe available in the source documents. There is no maximum duration for which aparticipant needs to be diagnosed with UC. If the pathology report to support adocumented diagnosis of UC is not available in the source documents, the screeningendoscopy with biopsies (obtained within 3 weeks before first study interventionadministration) needs to support the diagnosis of UC.

  • Moderately to severely active UC, defined by a baseline modified Mayo (withoutphysician's global assessment) score of 5 through 9 inclusive, with a screening Mayoendoscopy subscore >= 2 as determined by a central review of the video of theendoscopy

  • Medically stable based on physical examination, medical history, and vital signs,performed at screening. Any abnormalities must be consistent with the underlyingillness in the study population and this determination must be recorded in theparticipant's source documents and acknowledged by the investigator

  • Participants must have had an inadequate response and/or intolerance to biologictherapy and/or conventional therapies or be dependent upon corticosteroids

Exclusion

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-abdominalsurgery within 3 months of baseline

  • Have severe colitis or have evidence of Crohn's Disease (CD)

Study Design

Total Participants: 112
Treatment Group(s): 4
Primary Treatment: Guselkumab Intravenous
Phase: 3
Study Start date:
January 19, 2024
Estimated Completion Date:
August 14, 2028

Connect with a study center

  • Perth Children's Hospital

    Nedlands, 6009
    Australia

    Active - Recruiting

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

    Nedlands, 6009
    Australia

    Site Not Available

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

    Nedlands 2064874, 6009
    Australia

    Site Not Available

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101
    Australia

    Site Not Available

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane 2207259, 4101
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead, 2145
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead 2143973, 2145
    Australia

    Site Not Available

  • CHU Charleroi Chimay

    Charleroi, 6042
    Belgium

    Site Not Available

  • CHU Charleroi Chimay

    Charleroi 2800481, 6042
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • UZ Brussel

    Jette, 1090
    Belgium

    Site Not Available

  • UZ Brussel

    Jette 2794914, 1090
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Capital Institute of Pediatrics

    Beijing, 100020
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Capital Center For Children's health Capital Medical University

    Beijing 1816670, 100020
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing 1816670, 100191
    China

    Site Not Available

  • Changzhou No 2 Peoples Hospital

    Changzhou 1815456, 213004
    China

    Site Not Available

  • Changzhou No 2 Peoples Hospital

    Changzhou City, 213004
    China

    Site Not Available

  • Changzhou No.2 People's Hospital

    Changzhou City, 213004
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Active - Recruiting

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou, 310005
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, 310016
    China

    Site Not Available

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou 1808926, 310005
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai 1796236, 200025
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, 110004
    China

    Site Not Available

  • Shengjing Hospital Of China Medical University

    Shenyang 2034937, 110004
    China

    Site Not Available

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

    ZhengZhou, 450018
    China

    Site Not Available

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

    Zhengzhou 1784658, 450052
    China

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N 11746890, 8200
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre 2619528, 2650
    Denmark

    Site Not Available

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

    Bron 3029931, 69677
    France

    Site Not Available

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

    Bron cedex, 69677
    France

    Site Not Available

  • Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant

    Bron cedex, 69677
    France

    Active - Recruiting

  • Hopital Francois Mitterand

    Dijon, 21000
    France

    Site Not Available

  • Hopital Francois Mitterand

    Dijon 3021372, 21000
    France

    Site Not Available

  • CHRU Lille

    Lille 2998324, 59037
    France

    Site Not Available

  • CHRU Lille

    Lille Cedex, 59037
    France

    Site Not Available

  • APHP Hopital Robert Debre

    Paris, 75019
    France

    Site Not Available

  • APHP Hopital Robert Debre

    Paris 2988507, 75019
    France

    Site Not Available

  • CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • CHU Toulouse

    Toulouse 2972315, 31059
    France

    Site Not Available

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo 3182164, 24127
    Italy

    Site Not Available

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40133
    Italy

    Site Not Available

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna 3181928, 40133
    Italy

    Site Not Available

  • AOU Meyer

    Firenze, 50139
    Italy

    Site Not Available

  • AOU Meyer

    Florence 3176959, 50139
    Italy

    Site Not Available

  • Ospedale S. Spirito, Azienda Sanitaria Pescara

    Pescara, 65124
    Italy

    Site Not Available

  • Ospedale S. Spirito, Azienda Sanitaria Pescara

    Pescara 3171168, 65124
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma 8957247, 00161
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma 8957247, 00165
    Italy

    Site Not Available

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo 3168234, 71013
    Italy

    Site Not Available

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Site Not Available

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste 3165185, 34137
    Italy

    Site Not Available

  • Tokyo Metropolitan Children's Medical Center

    Fuchu, 183 8561
    Japan

    Site Not Available

  • Tokyo Metropolitan Children's Medical Center

    Fuchū 11611632, 183 8561
    Japan

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa, 920 8641
    Japan

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa 1860243, 920 8641
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe, 650 0017
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe 1859171, 650 0017
    Japan

    Site Not Available

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520
    Japan

    Site Not Available

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto 1858421, 861 8520
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto, 390 8621
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto 1857519, 390 8621
    Japan

    Site Not Available

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Site Not Available

  • Saga University Hospital

    Saga 1853303, 849-8501
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku, 160 0023
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku 11790353, 160 0023
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki 1850910, 569-8686
    Japan

    Site Not Available

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 230-8765
    Japan

    Site Not Available

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama 1848354, 230-8765
    Japan

    Site Not Available

  • Akershus Universitetssykehus

    Lørenskog, 1478
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo, 0450
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo 3143244, 0450
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge HF

    Tromso, 9030
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge HF

    Tromsø 3133895, 9030
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim 3133880, 7030
    Norway

    Site Not Available

  • Copernicus Podmiot Leczniczy Sp. z o.o

    Gdansk, 80 803
    Poland

    Site Not Available

  • Szpital im. M. Kopernika

    Gdansk, 80 803
    Poland

    Active - Recruiting

  • Copernicus Podmiot Leczniczy Sp. z o.o

    Gdansk 3099434, 80 803
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów 759734, 35-302
    Poland

    Site Not Available

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw 756135, 04 730
    Poland

    Site Not Available

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

    Warsaw 756135, 04 501
    Poland

    Site Not Available

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warszawa, 04 730
    Poland

    Site Not Available

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

    Warszawa, 04 501
    Poland

    Active - Recruiting

  • Chln - Hosp. Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Uls Santa Maria - Hosp. Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon 2267057, 1649-035
    Portugal

    Site Not Available

  • Chp - Centro Materno Infantil Do Norte

    Porto, 4050-651
    Portugal

    Active - Recruiting

  • Chsj - Hosp. Sao Joao

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Uls Santo Antonio - Cmin

    Porto, 4050-651
    Portugal

    Active - Recruiting

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319
    Portugal

    Site Not Available

  • Uls Santo Antonio - Cmin

    Porto 2735943, 4050-651
    Portugal

    Site Not Available

  • Uls Sao Joao - Hosp. Sao Joao

    Porto 2735943, 4200 319
    Portugal

    Site Not Available

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009
    Spain

    Site Not Available

  • Hosp. Infantil Univ. Nino Jesus

    Madrid 3117735, 28009
    Spain

    Site Not Available

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208
    Spain

    Site Not Available

  • Corporacio Sanitari Parc Tauli

    Sabadell 3111199, 08028
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    València, 46026
    Spain

    Site Not Available

  • Ankara University Medical Faculty

    Ankara, 6620
    Turkey

    Site Not Available

  • Gazi University Medical Faculty

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Marmara University Pendik Training Hospital

    Istanbul, 34899
    Turkey

    Site Not Available

  • Ankara University Medical Faculty

    Ankara 323786, 6620
    Turkey (Türkiye)

    Site Not Available

  • Gazi University Medical Faculty

    Ankara 323786, 06560
    Turkey (Türkiye)

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul 745044, 34098
    Turkey (Türkiye)

    Site Not Available

  • Marmara University Pendik Training Hospital

    Istanbul 745044, 34899
    Turkey (Türkiye)

    Site Not Available

  • Children's Hospital Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • Children's Hospital Oakland

    Oakland 5378538, California 5332921 94609
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • NYU Langone Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • NYU Langone Health

    Lake Success 5123853, New York 5128638 11042
    United States

    Site Not Available

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