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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 Crohn's Disease

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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 Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2026

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At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Crohn's disease
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms UNITI-Jr
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 15 Apr 2026 According to a Johnson & Johnson media release, the U.S. Food and Drug Administration (FDA) approved STELARA (ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohns disease
  • 25 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 05 Dec 2023 Status changed from recruiting to active, no longer recruiting.

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