A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Last updated: March 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Psoriatic Arthritis

Treatment

Guselkumab

Clinical Study ID

NCT06663332
CNTO1959ISD3001
CNTO1959ISD3001
2023-509560-16-00
  • Ages > 3
  • All Genders

Study Summary

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Eligibility Criteria

Inclusion

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 theinvestigator

  • Before enrollment, a participant must be either: (a) Not of childbearing potential,OR (b) Of childbearing potential and not sexually active, practicing abstinence or ahighly effective method of contraception and agrees to remain on a highly effectivemethod 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 consentform (ICF) indicating that he or she understands the purpose of, and proceduresrequired for, the study and is willing to allow the child to participate in thestudy. Assent is required from participants who are capable of understanding thenature of the study, typically those aged 7 years and older, to ensure theirwillingness to participate. An adolescent who provides assent will have theopportunity to sign an adult ICF upon reaching the age of majority, therebyaffirming their understanding of the study's purpose and procedures, as well astheir willingness to participate.

Exclusion

Exclusion Criteria:

  • Participant is greater than or equal to (>=) 18 years of age and resides in acountry where 2 years have elapsed post marketing authorization for the respectiveadult indication

  • Participant is <18 years of age and resides in a county where 2 years have elapsedpost 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 proposedstudy or other studies under the direction of that investigator or study site, aswell as family members of the employees or the investigator

  • Any condition for which, in the opinion of the investigator, participation would notbe in the best interest of the participant or that could prevent, limit, or confoundthe protocol-specified assessments

Study Design

Total Participants: 196
Treatment Group(s): 1
Primary Treatment: Guselkumab
Phase: 3
Study Start date:
October 29, 2024
Estimated Completion Date:
December 12, 2031

Connect with a study center

  • Instituto Caici

    Rosario, S2003CVB
    Argentina

    Active - Recruiting

  • Instituto Caici

    Rosario 3838583, S2003CVB
    Argentina

    Site Not Available

  • Capital Center For Children's health Capital Medical University

    Beijing, 100020
    China

    Active - Recruiting

  • Capital Center For Children's health Capital Medical University

    Beijing 1816670, 100020
    China

    Site Not Available

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213003
    China

    Active - Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou 1815456, 213003
    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

    Active - Recruiting

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou 1808926, 310005
    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, 110055
    China

    Active - Recruiting

  • Shengjing Hospital Of China Medical University

    Shenyang 2034937, 110055
    China

    Site Not Available

  • Hospital Center University De Lille

    Lille, 59000
    France

    Active - Recruiting

  • Hospital Center University De Lille

    Lille 2998324, 59000
    France

    Site Not Available

  • Schon Klinik Hamburg Eilbek

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Schon Klinik Hamburg Eilbek

    Hamburg 2911298, 22081
    Germany

    Site Not Available

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127
    Italy

    Active - Recruiting

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo 3182164, 24127
    Italy

    Site Not Available

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40121
    Italy

    Active - Recruiting

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna 3181928, 40121
    Italy

    Site Not Available

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo 3168234, 71013
    Italy

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa, 920 8641
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa 1860243, 920 8641
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe, 650 0017
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe 1859171, 650 0017
    Japan

    Site Not Available

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520
    Japan

    Active - Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto 1858421, 861 8520
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto, 390 8621
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto 1857519, 390 8621
    Japan

    Site Not Available

  • Saga University Hospital

    Saga, 849 0937
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga 1853303, 849 0937
    Japan

    Site Not Available

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

    Sosnowiec, 41 200
    Poland

    Active - Recruiting

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

    Sosnowiec 3085128, 41 200
    Poland

    Site Not Available

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730
    Poland

    Active - Recruiting

  • Medical Network

    Warsaw, 04-501
    Poland

    Active - Recruiting

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw 756135, 04-730
    Poland

    Active - Recruiting

  • Medical Network

    Warsaw 756135, 04-501
    Poland

    Site Not Available

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warszawa, 04-736
    Poland

    Site Not Available

  • Medical Network

    Warszawa, 04-501
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warszawa, 02 637
    Poland

    Suspended

  • Uls Braga - Hosp. Braga

    Braga, 4710 243
    Portugal

    Active - Recruiting

  • Uls Braga - Hosp. Braga

    Braga 2742032, 4710 243
    Portugal

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela 3109642, 15706
    Spain

    Site Not Available

  • Gazi University Medical Faculty

    Ankara, 06560
    Turkey

    Site Not Available

  • Umraniye Training and Research Hospital

    Istanbul, 34764
    Turkey

    Site Not Available

  • Gazi University Medical Faculty

    Ankara, 06560
    Turkey (Türkiye)

    Active - Recruiting

  • Gazi University Medical Faculty

    Ankara 323786, 06560
    Turkey (Türkiye)

    Site Not Available

  • Umraniye Training and Research Hospital

    Istanbul, 34764
    Turkey (Türkiye)

    Active - Recruiting

  • Umraniye Training and Research Hospital

    Istanbul 745044, 34764
    Turkey (Türkiye)

    Site Not Available

  • Kocaeli Universitesi Hastanesi

    Kocaeli, 41380
    Turkey (Türkiye)

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Riley Hospital for Children

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84113
    United States

    Site Not Available

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