ClinicalTrials.gov
Cure8 trial brief
Why This Matters
People with IBD who have no or few symptoms but still have moderate–severe inflammation on endoscopy face uncertainty about whether to switch therapies to aim for endoscopic remission.
This trial tests whether actively switching to a different targeted immunomodulator is better than staying on the current optimized drug. Results could influence how clinicians use treat-to-target strategies and decisions about changing biologics or other TIMs when patients feel well but have ongoing inflammation.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis (especially those in symptomatic remission but with endoscopic inflammation); clinicians who manage IBD and make medication-switching decisions; researchers studying treat-to-target strategies and TIM positioning; patients on biologics or other targeted immunomodulators.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment216 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a randomized, pragmatic multicenter trial testing a treat-to-target strategy: switching to an alternative targeted immunomodulator (TIM) versus continuing the current optimized TIM in patients with Crohn’s disease or ulcerative colitis who are in symptomatic remission but have moderate–severe endoscopic inflammation.
The study will follow participants up to 104 weeks, with the primary outcome time to treatment failure defined as a composite of symptomatic relapse with objective inflammatory confirmation, need for rescue steroids, hospitalization, surgery, structural complications, or drug discontinuation for adverse events.
Patients randomized to switch will be prescribed an alternative guideline-preferred TIM chosen by their treating clinician and covered by insurance; no study drug is provided.
Data collection is embedded in routine care and uses PRO measures (PRO2 and other questionnaires), medical record extraction, and laboratory/imaging/endoscopy results captured in an EDC database. The trial is pragmatic and open-label; visit schedules follow local standard of care and treatment changes are allowed per treating teams.
Outcomes include clinical events, quality of life, treatment burden, satisfaction, and safety.
Keep In Mind
This is a pragmatic, open-label randomized trial embedded in routine care; no study drugs are supplied and choice of alternative TIM is determined by treating physicians based on guidelines and insurance coverage. Because visits follow local standard of care, monitoring intensity may vary across sites.
The registry record describes study design and planned outcomes but does not report results.
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
SponsorMayo Clinic
Trial IDNCT05230173
Study typeInterventional
Trial phaseNA
Enrollment216 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 7, 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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