UNITI JR: Ustekinumab in Paediatric Crohn's Disease
Research type
Research Study
Full title
A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease
IRAS ID
290821
Contact name
Rafeeq Muhammed
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2019-004225-24
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
Crohn’s disease is a chronic inflammatory bowel disorder of unknown cause, which can affect any part of the digestive tract. Crohn’s disease is most commonly diagnosed in late adolescence and early adulthood, but a diagnosis may occur at any age. Clinically, patients with Crohn's suffer from discontinuous focal ulcerations, fistula formation, granulomas, and perianal involvement. There is a high unmet need for new treatment options in Crohn’s disease in paediatric populations, that are safe and effective, especially new therapies that can provide improved long-term efficacy (ie sustained remission) over currently available therapies within the UK NHS hospitals.
The UNITI Jr study is looking to evaluate the effectiveness and safety of a treatment, Ustekinumab, in paediatric participants (aged 2 to <18 years of age) with Crohn’s disease. Ustekinumab has been approved for the treatment of adults and pediatric patients with moderate to severe plaque psoriasis and adult patients with active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active Ulcerative colitis.
Participants will be first screened for eligibility. They will then enter the Induction period where all participants will receive a single open-label IV administration of ustekinumab. Participants will then enter the maintenance period where all participants will be randomly assigned to receive ustekinumab (either every 8 or every 12 weeks) or a matched placebo to keep the blind. There will be a safety follow up visit 20 weeks after the last administration of study intervention.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0327
Date of REC Opinion
3 Feb 2021
REC opinion
Further Information Favourable Opinion