A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Summary

The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

Timeline

Start

2018-12-20

Primary completion

2022-08-19

Completion

2023-01-10

Publications

• Schreiber S, Lee SD, van der Woude CJ, Marin-Jimenez I, Wolf DC, Schnoy E, Salzberg B, Busse C, Nazar M, Ma T, Borghorst S, Gasink C, Baker T, Godwin B, Adedokun OJ, Feagan BG; POWER Study Group. Ustekinumab Intravenous Reinduction after Secondary Loss of Response in Patients with Crohn's Disease. Inflamm Bowel Dis. 2025 Dec 1;31(12):3286-3297. doi: 10.1093/ibd/izaf163.
• Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
• Ten Bokkel Huinink S, Biemans V, Duijvestein M, Pierik M, Hoentjen F, West RL, van der Woude CJ, de Vries AC. Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e783-e788. doi: 10.1097/MEG.0000000000002256.

Drugs

Indications