ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Hospitalized patients with acute severe ulcerative colitis face high short-term risk of colectomy and need effective rescue strategies; this trial tests a personalized, adaptive approach to inpatient medical therapy and aims to learn whether those pathways are feasible and acceptable before a larger efficacy trial.
Who Should Pay Attention
Adults hospitalized with ASUC, inpatient gastroenterology teams, IBD clinicians, clinical researchers designing adaptive trials, and patients weighing trial participation.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment700 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes a pilot SMART (sequential multiple assignment randomized trial) testing adaptive inpatient treatment pathways for adults hospitalized with acute severe ulcerative colitis (ASUC).
The interventional arm randomizes patients to corticosteroid-based induction with possible additions or switches to upadacitinib or intravenous cyclosporine as rescue therapy; it also includes transitions to oral therapy and planned therapeutic drug monitoring for cyclosporine.
The study is primarily assessing feasibility and acceptability, with secondary efficacy outcomes and a large observational comparator group.
The trial enrolls adults with ASUC, includes qualitative interviews with patients and clinicians to assess barriers and acceptability, and will collect prospective and retrospective comparator data to contextualize outcomes.
Registered interventions and dosing strategies are specified for IV methylprednisolone, oral prednisone taper, IV and oral cyclosporine (with blood level targets), and upadacitinib dosing strategies during hospitalization and after discharge.
This is a pilot/feasibility study (Phase 4 per the registry) intended to inform a larger definitive trial; it is not reporting results. If you’re considering participation, discuss eligibility, potential risks, and local standard of care with the study team and your gastroenterologist.
Keep In Mind
This registry entry is a trial protocol and does not report results. The study is focused on feasibility and acceptability rather than demonstrating clinical benefit; drug dosing, monitoring plans, and switching rules are protocol-defined. Enrollment is listed as recruiting; contact the study site for eligibility and risks.
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
SponsorBerinstein, Jeffrey
Trial IDNCT05867329
Study typeInterventional
Trial phasePhase 4
Enrollment700 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 11, 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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