ClinicaliQ Trial Snapshot
- A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants — Recruiting • Phase III • Rheumatology • NCT06663332.
- Treatment being tested: Long-term safety and efficacy of guselkumab (an IL-23 inhibitor administered subcutaneously) in pediatric patients with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis.
- Patient eligibility overview: Pediatric participants with confirmed diagnoses of moderately to severely active inflammatory bowel disease (ulcerative colitis or Crohn's disease) or juvenile psoriatic arthritis who have enrolled from preceding guselkumab trials.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.