UNITED
Research type
Research Study
Full title
A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)
IRAS ID
1005154
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-004457-76
Clinicaltrials.gov Identifier
Research summary
Ustekinumab is a study drug that has been studied in adult participants with Crohn’s disease, ulcerative colitis and psoriatic arthritis. It is now being studied in paediatric participants with the conditions of paediatric Crohn’s disease, paediatric ulcerative colitis and juvenile psoriatic arthritis. The purpose of this study is to collect long‐term safety data in those paediatric study participants and to provide continued access to the study drug ustekinumab to the paediatric study participants, who in the opinion of the investigator, will continue to benefit from ustekinumab therapy. This study is considered a long‐term extension (LTE) study.
Eligible participants, who successfully completed one of four primary studies, will be able to take part in this worldwide study for at least a year. Participants can be male or female and aged 2 – 17 years old at the time of signing the informed consent to join the study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0019
Date of REC Opinion
12 Jul 2023
REC opinion
Further Information Favourable Opinion