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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3+
SponsorJanssen Research & Development, LLC

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Guselkumab

Treatment groups

196 Participants
are divided into 2 treatment groups