At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
Ustekinumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Loss of RESponse to Ustekinumab Treated by Dose Escalation
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW·interventional·Posted Jan 28, 2020·Updated Apr 13, 2026
In Brief
A Phase 3 clinical trial evaluating Ustekinumab for Crohn Disease. Completed, enrolled 108 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesBelgium
CollaboratorsJanssen Cilag N.V./S.A.
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartMar 2020
Primary CompletionSep 2024
TodayJul 2026
First PostedJan 28, 2020
Enrollment StartMar 11, 2020
Primary CompletionSep 25, 2024
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.4 years ago
Interventions
Ustekinumabdrug
re-induction and dose escalation form every 8 weeks to every 4 weeks only in arm 2