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

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Psoriatic Arthritis

Inflammatory Bowel Disease

Joint Injuries

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

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213003
    China

    Active - Recruiting

  • Kobe University Hospital

    Kobe, 650 0017
    Japan

    Active - Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520
    Japan

    Active - Recruiting

  • 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

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

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