BENITIONSClinical Trial Intelligence

Loss of RESponse to Ustekinumab Treated by Dose Escalation

Phase 3 Completed NCT04245215

ConditionCrohn Disease
PhasePhase 3
SponsorBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
StatusCompleted
Enrollment108 participants
InterventionsUstekinumab
Start dateMar 11, 2020
Completion dateSep 25, 2024
Results postedApr 13, 2026

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

Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48

week 48 · Participants

Ustekinumab q4w8 Participants
Ustekinumab q8w10 Participants
p-value0.5
Risk Difference (RD)0.0502 (95% CI -0.09487–0.1953)

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