ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Knowing which treatment target (symptom control alone versus adding endoscopic and histological remission) leads to better long-term outcomes could change how aggressively clinicians treat ulcerative colitis and what goals are used in clinical practice and drug trials.
This study tested those targets in a large, randomized, interventional protocol with predefined treatment algorithms.
Who Should Pay Attention
Clinicians treating UC, researchers and trialists designing UC endpoints, adult patients with moderate-to-severe ulcerative colitis, and patients on or considering biologic therapy.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment672 participants
Study statusCompleted
Source depthTrial registry record
What To Know
The study tested whether aiming for more stringent targets (symptoms alone vs symptoms+endoscopic remission vs symptoms+endoscopic+histological remission) affects outcomes like time to UC-related complications.
Treatment algorithms in the protocol specify standard first-line therapies, switching to intravenous vedolizumab for participants on certain prior regimens, and dose escalation if the assigned target is not met.
The trial was completed and enrolled a planned large cohort; randomization ratios were adjusted after interim review to achieve target numbers per group. The registry entry lists primary outcomes and key eligibility criteria but does not report trial results in this record.
If you want to know what the study found, look for a peer-reviewed publication or a results posting linked from the ClinicalTrials.gov record; this registry entry describes the design and interventions rather than outcome data.
Keep In Mind
This record is a trial registry entry (phase 4, completed) and describes study design, interventions, and outcomes to be measured; it does not present results. For findings, check the ClinicalTrials.gov "Results" section or a peer-reviewed publication.
The entry includes protocol-specified drug switches (including vedolizumab) and dose-escalation rules, which reflect the study design rather than treatment recommendations.
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
SponsorAlimentiv Inc.
Trial IDNCT04259138
Study typeInterventional
Trial phasePhase 4
Enrollment672 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 10, 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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