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Taking people in AustraliaPhase 3

Long-term safety of guselkumab in young patients with Crohn's, colitis, or juvenile arthritis

Tests long-term safety of guselkumab in children with Crohn's, colitis, or juvenile psoriatic arthritis.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Nedlands, South Brisbane, and Westmead, AustraliaSee the 3 sitesAlso in 17 other countries, 55 sites
Registry title
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Status
Recruiting
Phase
Phase 3
People taking part
196 people, planned
Started
29 Oct 2024
Expected to end
25 Feb 2032
Type of study
Interventional, 2 groups
Treatments tested
  • Guselkumab
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people who finished the main guselkumab study for Crohn's disease, ulcerative colitis or juvenile psoriatic arthritis and benefited from the treatment.

Age
3 Years to 64 Years
Sex
All sexes can join.
Disease stage
Moderately to severely active Crohn's disease or ulcerative colitis, or juvenile psoriatic arthritis (jPsA).
Earlier treatment
Must have completed the dosing planned in the primary pediatric guselkumab study. The investigator must see a benefit from continued guselkumab. Disallowed therapies before the first extension dose are not permitted.

Main reasons for not taking part

  • Pregnant, nursing, or planning pregnancy or fathering a child
  • Taken any disallowed therapies before the first extension dose
  • Living in a country where 2 years have passed since marketing authorization for the person's indication
  • Employee of the investigator or study site, or a family member of one
  • Any condition the investigator thinks could limit or confuse the study assessments

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Must have completed the dosing planned in the primary pediatric guselkumab study
  • Must have received benefit from continued guselkumab therapy in the opinion of the investigator
  • Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method 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 consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate

Who cannot take part

  • Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
  • Participant is greater than or equal to (>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication
  • Participant is <18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication
  • Are pregnant, nursing, or planning pregnancy or fathering a child
  • Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 3 and 64 years old?

Where in Australia

Also in 17 other countries, 55 sites

  • The Kids Research Institute Australia on behalf of the Centre for Child Health ResearchNedlands, AustraliaTaking people
  • Mater Hospital Brisbane Inflammatory Bowel DiseasesSouth Brisbane, AustraliaTaking people
  • The Children's Hospital at WestmeadWestmead, AustraliaTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Guselkumab (Every 8 weeks)Treatment being tested

    Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks \[q8w\]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study.

    Treatment: Guselkumab

  • Guselkumab (Every 4 weeks)Treatment being tested

    Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study.

    Treatment: Guselkumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis
Plain-language title
Long-term safety of guselkumab in young patients with Crohn's, colitis, or juvenile arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06663332, who can take part
Record updated
3 November 2026