Loss of RESponse to Ustekinumab Treated by Dose Escalation

Phase 3 Completed 108 enrolled Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW Janssen Cilag N.V./S.A. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time

Timeline

Start: 2020-03-11
Primary completion: 2024-09-25
Completion: 2024-09-25

Publications

Bossuyt P, Rahier JF, Baert F, Louis E, Macken E, Lobaton T, Busschaert J, Peeters H, Dewint P, Franchimont D, Willandt B, Claessens C, Vansteenkiste L, Dewit O, Ferrante M; Belgian IBD Research and Development (BIRD) group; Vermeire S. The Effect of Dose Intensification After Secondary Loss of Response to Ustekinumab in Crohn's Disease: Results of the REScUE Study. Gastroenterology. 2026 Jul;171(1):99-109. doi: 10.1053/j.gastro.2026.01.042. Epub 2026 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ustekinumab	Monoclonal antibody	90 mg	Intravenous

Loss of RESponse to Ustekinumab Treated by Dose Escalation

Summary

Timeline

Publications

Drugs

Indications