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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Feb 2026

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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

Most Recent Events

  • 23 Jan 2026 According to a Johnson & Johnson media release, company has applied for marketing approval for the treatment of intravenous and subcutaneous formulations of Stelara (generic name: ustekinumab (genetically modified), hereinafter referred to as Stelara) for the treatment of pediatric patients with moderate to severe ulcerative colitis (UC).
  • 31 Oct 2025 According to a Johnson & Johnson media release, company announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of STELARA (ustekinumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC).
  • 18 Jul 2025 Status changed from active, no longer recruiting to completed.

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