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Long-term evaluation of guselkumab for children with inflammatory bowel disease and juvenile arthritis

A Phase 3, Multicenter, Open-label, Basket, LTE Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

Phase 3 Interventional Janssen Research & Development, LLC · NCT06663332

This study tests how safe and effective the medication guselkumab is for children with inflammatory bowel disease or juvenile arthritis over a long period of time.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment196 (estimated)
Ages3 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsguselkumab
Locations42 sites (Atlanta, Georgia and 41 other locations)
Trial IDNCT06663332 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety of guselkumab, a medication administered subcutaneously, in pediatric patients suffering from moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. Participants must have previously completed a primary study involving guselkumab and demonstrated benefit from the therapy. The study aims to gather data on the ongoing effects and safety profile of the treatment over an extended period.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients who have completed prior treatment with guselkumab and have shown a positive response to the therapy.

Not a fit: Patients who have not previously benefited from guselkumab therapy or those who have not completed the primary study will not receive benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of guselkumab for treating serious inflammatory conditions in children.

How similar studies have performed: Other studies have shown promising results with guselkumab in adult populations, but this specific long-term evaluation in pediatric patients is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.

Exclusion Criteria:

* 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
* 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 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
* 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

Where this trial is running

Atlanta, Georgia and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohns DiseaseColitis, UlcerativeArthritis, PsoriaticArthritis, Juvenile
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.