ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This OLE study follows patients who lost response to ustekinumab every-8-week dosing and evaluates whether increasing to every-4-week dosing maintains efficacy and safety long-term. That question is directly relevant to patients and clinicians facing secondary loss of response on ustekinumab.
Who Should Pay Attention
Adults with Crohn's disease on ustekinumab, clinicians treating IBD and managing dose escalation, researchers studying biologic dosing strategies and long-term safety.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 3
Enrollment41 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This trial (RESCUE-OLE, NCT05299931) enrolled patients who completed the parent REScUE study and documents protocol rules for who continues or switches dosing. The study includes standard monitoring such as endoscopy (carried over from the parent study), labs including liver tests and creatinine, and patient-reported fatigue (FACIT-Fatigue).
Exclusions include ongoing use of another biologic or JAK inhibitor, untreated abscesses, impassable stenosis despite dilation, or active infections until resolved. The OLE design means participants and investigators know the treatment, and treatment allocation depends on response status at the end of the parent REScUE study.
Safety and efficacy are being followed over the long term after dose escalation for those with secondary loss of response.
Keep In Mind
This is a trial record (phase 3 open-label extension) describing protocol, eligibility, and monitoring plans—no efficacy or safety results are reported in this record. The OLE enrolls only patients from the parent REScUE trial and uses prior endoscopy data to avoid repeat procedures at baseline.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Trial IDNCT05299931
Study typeInterventional
Trial phasePhase 3
Enrollment41 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 13, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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