A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Summary

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn's disease.

Timeline

Start

2021-04-06

Primary completion

2024-11-28

Completion

2025-03-03

Publications

• De Greef E, Turner D, Kierkus J, Korczowski B, Meglicka M, Cohen SA, Hyams JS, Griffiths AM, Rosh JR, Strauss R, Van Limbergen E, Adedokun OJ, Kim L, Volger S; UNITI Jr study Group. Ustekinumab therapy for moderately to severely active pediatric Crohn's disease: UNITI Jr study safety and efficacy results in patients weighing at least 40 kg. J Crohns Colitis. 2026 Mar 10;20(3):jjag011. doi: 10.1093/ecco-jcc/jjag011.

Drugs

Indications