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NCT05299931 · ClinicalTrials.gov record · last posted 2025-02-05

An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study

Study acronym: REScUE-OLE
StatusActive, Not Recruiting
PhasePhase 3
Started2021-09-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 5, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
The aim of the study is to assess the long-term efficacy and safety of a ustekinumab 90mg subcutaneous (SC) every 4 weeks (Q4w) regimen in patients with Crohn's disease previously enrolled in the REScUE study (NCT04245215) because of secondary loss of response to a ustekinumab 90mg SC every 8 weeks (Q8w) regimen.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2022-03-18; most recent amendment 2025-02-03. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-09-27
Status change Recruiting→Active, Not Recruitingv2
Trial Details
NCT Number NCT05299931
Lead Sponsor Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborators: Janssen Cilag N.V./S.A.
Conditions Crohn Disease
Enrollment 108 participants
Start Date 2021-09-10
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-02-05