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.
Plain-language title generated from the registry record
Registry title: A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Key facts
- Where
- Ankara, Istanbul, and Kocaeli, TürkiyeSee the 3 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT06663332, who can take part
Where in Türkiye
- Gazi University Medical FacultyAnkara, TürkiyeTaking people
- Ümraniye Training and Research HospitalIstanbul, TürkiyeTaking people
- Kocaeli Universitesi HastanesiKocaeli, TürkiyeTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06663332EU 2023-509560-16-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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.