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

In plain English

What this trial is testing

This study is testing Guselkumab (a drug). Condition(s) listed: Crohns Disease, Colitis, Ulcerative and Arthritis, Psoriatic.

It is open-label: participants know what they are receiving.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 3 and older
• Any sex

Some of the main requirements, copied from the record:

• 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…
• 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…

There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 196 participants are expected to take part.
• The study has 2 groups.
• Start date: 2024-10-29.
• Main results expected around 2031-12-12 (estimate from the record).
• 51 study sites listed (51 marked recruiting) in Argentina, Australia, Belgium, Brazil and China and 12 more countries.

Groups in this study

• Guselkumab (Every 8 weeks) (listed as: experimental group)
• Guselkumab (Every 4 weeks) (listed as: experimental group)

Main thing being measured

• Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety (Up to 6 years and 9 months)

In the researchers’ words

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).

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.