Janssen posts UNIFI Jr Phase 3 pediatric ulcerative colitis results for ustekinumab

Janssen Research & Development's pediatric ulcerative colitis trial for ustekinumab (Stelara) reported results this week after completing enrollment and follow-up.

• The Phase 3 study, known as "UNIFI Jr" (NCT04630028), tested intravenous ustekinumab induction followed by randomized subcutaneous maintenance dosing in 112 pediatric participants with moderately to severely active ulcerative colitis.¹
• The trial's primary efficacy measure was the percentage of participants achieving clinical remission at induction Week 8, defined by Mayo subscores including stool frequency, rectal bleeding, and endoscopy criteria.¹
• The study was first posted on November 16, 2020, with actual start on March 17, 2021, primary completion on May 8, 2025, and study completion on June 5, 2025.¹ Results were first posted on October 20, 2026.
• Safety outcomes tracked included the number of participants with treatment-emergent adverse events during both the induction and maintenance periods¹, along with serious adverse events and discontinuations due to adverse events.