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 Ulcerative Colitis
Latest Information Update: 24 May 2024
At a glance
- Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
- Indications Ulcerative colitis
- Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms UNIFI Jr
- Sponsors Janssen Research & Development; Janssen-Cilag
- 21 May 2024 Status changed from recruiting to active, no longer recruiting.
- 27 Feb 2024 Planned number of patients changed from 100 to 110.
- 07 Nov 2023 Planned End Date changed from 25 Jul 2025 to 7 Nov 2025.